RA_Report)# RA_CAERS)Created)Date
AEC_Event)Start)Date
PRI_Product)Role
PRI_Reported)Brand/Product)Name
PRI_FDA)Industry)Code
PRI_FDA)Industry)Name
73168
10/22/04
5/18/04 Suspect
HENNA)GORA)BLACK)CREAM)FORMULA)FOR)EYEBROWS)AND
53 Cosmetics
75793
2/2/05
Suspect
REVLON)LASH)FANTASY)MASCARA,)BLACK,)WATERPROOF
53 Cosmetics
77741
4/28/05
Suspect
MAYBELLINE)GREAT)LASH)MASCARA)(BROWNISH)BLACK)
53 Cosmetics
80360
8/25/05
Suspect
MAYBELLINE)GREAT)LASH)BLACKEST)BLACK)MASCARA)(365M
53 Cosmetics
98153
11/20/07
11/9/07 Suspect
JAN)MARINI)AGE)INTERVENTION)EYELASH
53 Cosmetics
98392
11/30/07
9/12/06 Suspect
JAN)MARINI)AGE)INTERVENTION)EYELASH
53 Cosmetics
99010
12/20/07
8/7/07 Suspect
JAN)MARINI)SKIN)RESEARCH)AGE)INTERVENTION)EYELASH)CO
53 Cosmetics
100191
2/7/08
1/30/08 Suspect
TOO)YOUNG)LASHES)EYELASH)EXTENSION)ADHESIVE)GLUE)KI
53 Cosmetics
101703
3/28/08
Suspect
JAN)MARINI)LASH)INTERVENTION
53 Cosmetics
102303
4/11/08
9/28/07 Suspect
ARDELL)LASHGRIP)EYELASH)ADHESIVE
53 Cosmetics
103823
6/12/08
Suspect
HEADCOVERS)UNLIMITED)EYELASH)AND)EYEBROW)GLUE
53 Cosmetics
106100
9/10/08
Suspect
INTENSIVE)EYE)LASH)TINT
53 Cosmetics
106771
10/1/08
8/18/08 Suspect
COVER)GIRL)VERY)BLACK)TRES)NOIR)8151)FANTASTIC)LASH)M
53 Cosmetics
109114
1/10/09
8/30/08 Suspect
RE)VITA)LASH)EYELASH)LENGTHENER
53 Cosmetics
115084
7/3/09
Suspect
ARDELL)LASHTITE)EYELASH)ADHESIVE
53 Cosmetics
120233
11/13/09
3/16/08 Suspect
MAYBELLINE)GREAT)LASH)MASCARA
53 Cosmetics
123035
2/4/10
Suspect
REFECTO)CIL)EYELASH)AND)EYEBROW)DYE
53 Cosmetics
128541
7/30/10
7/24/10 Suspect
L'OREAL)LASH)BOOSTING)SERUM
53 Cosmetics
129179
8/19/10
Suspect
DUO)EYELASH)ADHESIVE)DARK)TONE
53 Cosmetics
131683
11/3/10
8/20/10 Suspect
EYELASH)TINT
53 Cosmetics
139755
6/3/11
5/25/11 Suspect
REVITALASH)EYELASH)CONDITIONER
53 Cosmetics
142067
8/3/11
Suspect
ARDELL)EYE)LASH)ADHESIVE
53 Cosmetics
142067
8/3/11
Suspect
DUO)EYELASH)ADHESIVE
53 Cosmetics
142138
8/4/11
Suspect
COVER)GIRL)LASH)BLAST53 Cosmetics
143002
9/1/11
8/25/11 Suspect
3D)BEAUTY)EYELASH)EXTENSION)ADHESIVE
53 Cosmetics
154707
7/24/12
3/27/12 Suspect
MAYBELLINE)GREAT)LASH)WATERPROOF)MASCARA
53 Cosmetics
155364
8/11/12
Suspect
NOVA)LASH)NOVA)LASH)PLATINIUM
53 Cosmetics
155416
8/14/12
3/28/12 Suspect
GREAT)LASH)WATER)PROOF)MASCARA
53 Cosmetics
161616
1/30/13
1/2/13 Suspect
LA)COLORS)PERFECT)LASH)MASCARA
53 Cosmetics
165541
5/15/13
Suspect
OLAY)MICRO[SCULPTING)EYE)CREAM)&)LASH)SERUM
53 Cosmetics
173288
1/18/14
Suspect
LILASH)PURIFIED)EYELASH)SERUM
53 Cosmetics
173494
1/29/14
1/24/14 Suspect
INTENSE)INTENSE)EYE)LASH)TINT
53 Cosmetics
175965
4/22/14
5/14/13 Suspect
BENEFIT)EYELASH)TINT 53 Cosmetics
177264
6/19/14
6/11/14 Suspect
BE)A)BOMBSHELL)COSMETICS)LASH)OUT!)MASCARA
53 Cosmetics
177347
6/24/14
6/12/14 Suspect
BE)A)BOMBSHELL)LASH)OUT)MASCARA)BATCH)310
53 Cosmetics
181141
12/3/14
11/22/14 Suspect
GRANDELASH[)MD)EYELASH)FORMULA
53 Cosmetics
181142
12/3/14
10/1/14 Suspect
RAPID)LASH
53 Cosmetics
181805
1/8/15
12/31/14 Suspect
ARDELL)FAKE)EYELASHES
53 Cosmetics
181830
1/9/15
10/8/14 Suspect
LAVISH)LASH
53 Cosmetics
183816
3/17/15
3/2/15 Suspect
MAYBELLINE)GREAT)LASH
53 Cosmetics
185867
5/8/15
4/26/15 Suspect
VIDI)EYELASH)SERUM 53 Cosmetics

 187707
191904
192401
192406
193013
194066
197799
199043
200385
201655

7/7/15
12/7/15
12/30/15
12/30/15
1/27/16
3/3/16
6/29/16
7/29/16
8/22/16
9/21/16

7/3/15
11/5/15
12/17/15
12/1/15
7/20/15
2/28/16
6/27/16
7/25/16
8/17/16

Suspect
Suspect
Suspect
Suspect
Suspect
Suspect
Suspect
Suspect
Suspect
Suspect

COVER)GIRL)LASH)BLAST)VOLUME)WATERPROOF)MASCARA
53 Cosmetics
GEN)X)PRODUCTS)LASH)RENEW
53 Cosmetics
LASH)RENEW
53 Cosmetics
REVLON)LASH)POTION)MASCARA
53 Cosmetics
EYE)BOOST)INSTANT)LASH)EXTENSION))MASCARA
53 Cosmetics
MAYBELLINE)LASH)SENSATIONAL)MASCARA
53 Cosmetics
LASH)SERUM)PLUS
53 Cosmetics
LASH)SERUM)PLUS
53 Cosmetics
HOUSE)OF)LASHES)EYELASH)ADHESIVE
53 Cosmetics
MAYBELLINE)GREAT)LASH)MASCARA
53 Cosmetics

 CI_Age)at)Adverse)Event
CI_Age)Unit CI_Gender AEC_One)Row)Outcomes
SYM_One)Row)Coded)Symptoms
27 Year(s)
Not)AvailableVISITED)A)HEALTH)CARE)PROVIDER
BURNING)SENSATION,)SKIN)IRRITATION,)SWELLING,)CONJUN
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)REDNESS,)SWELLING,)KERATOCONJUNCTIVITIS)SICCA
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
RASH,)ERYTHEMA
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
SWELLING,)EYE)IRRITATION
45 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER
VISION)BLURRED,)HYPERSENSITIVITY,)INFLAMMATION,)EYE)S
58 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS),)VISITED)A)HEALTH)CARE)
PHOTOPSIA,)RETINAL)TEAR
65 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS),)VISITED)A)HEALTH)CARE)
VISUAL)ACUITY)REDUCED,)OPTIC)NERVE)INJURY
41 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
EYE)INFECTION,)EYE)IRRITATION,)KERATITIS,)DISCOMFORT
Not)AvailableNot)AvailableDISABILITY,)VISITED)A)HEALTH)CARE)PROVIDER,)OTHER)SERIOUS)(IMPORTA
BLINDNESS,)OPTIC)NEURITIS,)RETINAL)DISORDER,)EYE)DISORD
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)INFLAMMATION,)EYE)SWELLING,)VISION)BLURRED
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)SWELLING,)CHEMICAL)BURN)OF)SKIN,)SCAR,)IMPAIRED)W
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
CAUSTIC)INJURY,)OCULAR)HYPERAEMIA,)EYE)PAIN,)TENDERN
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
MADAROSIS
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
HEADACHE,)VISION)BLURRED
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
SKIN)IRRITATION,)FOREIGN)BODY)TRAUMA
40 Year(s)
Female
NON[SERIOUS)INJURIES/)ILLNESS
PRURITUS,)OCULAR)HYPERAEMIA,)SWELLING
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
THERMAL)BURN
36 Year(s)
Female
NON[SERIOUS)INJURIES/)ILLNESS
EYE)PAIN,)EYE)SWELLING,)FLUID)RETENTION
41 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER
EYE)IRRITATION,)DANDRUFF,)ACNE,)SKIN)EXFOLIATION
31 Year(s)
Female
VISITED)AN)ER,)VISITED)A)HEALTH)CARE)PROVIDER,)HOSPITALIZATION
EYE)IRRITATION,)CAUSTIC)INJURY,)EYE)SWELLING,)LACRIMATI
71 Year(s)
Female
NON[SERIOUS)INJURIES/)ILLNESS
OCULAR)HYPERAEMIA,)EYE)PAIN,)EYE)IRRITATION
22 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
HYPERSENSITIVITY,)SWELLING,)SWELLING,)EYE)PRURITUS
22 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
HYPERSENSITIVITY,)SWELLING,)SWELLING,)EYE)PRURITUS
40 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER
ERYTHEMA,)INFLAMMATION,)HYPERSENSITIVITY,)ORAL)DISCO
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
SWELLING,)OCULAR)HYPERAEMIA,)HYPERSENSITIVITY
Not)AvailableFemale
VISITED)A)HEALTH)CARE)PROVIDER,)NON[SERIOUS)INJURIES/)ILLNESS
BLISTER,)BURNING)SENSATION,)EYE)SWELLING
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)IRRITATION,)VISION)BLURRED,)LYMPHADENOPATHY,)BUR
61 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
ERYTHEMA,)INFECTION,)SWELLING
17 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER
VISION)BLURRED,)BURNING)SENSATION,)HYPERSENSITIVITY
25 Year(s)
Not)AvailableNON[SERIOUS)INJURIES/)ILLNESS
HYPERSENSITIVITY,)LIP)SWELLING,)EYE)PRURITUS
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)IRRITATION
44 Year(s)
Female
HOSPITALIZATION
EYE)SWELLING,)OCULAR)HYPERAEMIA,)EYE)DISCHARGE
35 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER
EYE)IRRITATION,)EYE)SWELLING,)FACE)OEDEMA
35 Year(s)
Female
NON[SERIOUS)INJURIES/)ILLNESS
LACRIMATION)INCREASED,)EYE)PRURITUS,)OCULAR)HYPERAE
Not)AvailableFemale
NON[SERIOUS)INJURIES/)ILLNESS
EYE)IRRITATION,)NAUSEA
47 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
SKIN)EXFOLIATION,)SKIN)IRRITATION,)INFLAMMATION
48 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
ACNE,)EYELID)BOIL,)EYELID)CYST,)BLOOD)TESTOSTERONE)INC
45 Year(s)
Female
VISITED)A)HEALTH)CARE)PROVIDER,)VISITED)AN)ER
HEADACHE,)VISION)BLURRED,)BURNING)SENSATION,)PAIN,)B
41 Year(s)
Female
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
HYPERSENSITIVITY,)HAEMORRHAGE
29 Year(s)
Female
NON[SERIOUS)INJURIES/)ILLNESS
PRURITUS,)SKIN)EXFOLIATION,)SWELLING
Not)AvailableFemale
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
BURNING)SENSATION,)PRURITUS,)OCULAR)HYPERAEMIA,)EYE

 26
57
49
62
32
19
61
50
27
40

Year(s)
Year(s)
Year(s)
Year(s)
Year(s)
Year(s)
Year(s)
Year(s)
Year(s)
Year(s)

Female
Female
Female
Female
Female
Male
Female
Female
Female
Female

VISITED)A)HEALTH)CARE)PROVIDER,)NON[SERIOUS)INJURIES/)ILLNESS
EYE)INFECTION
NON[SERIOUS)INJURIES/)ILLNESS
PRURITUS,)EYE)IRRITATION
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
EYE)IRRITATION,)EYELID)RASH
VISITED)A)HEALTH)CARE)PROVIDER,)OTHER)SERIOUS)(IMPORTANT)MEDICA
EYE)PAIN,)ERYTHEMA)OF)EYELID,)PHOTOPHOBIA
NON[SERIOUS)INJURIES/)ILLNESS
OCULAR)HYPERAEMIA,)EYE)PAIN,)LACRIMATION)INCREASED
NON[SERIOUS)INJURIES/)ILLNESS
EYE)INFECTION
NON[SERIOUS)INJURIES/)ILLNESS
BURNING)SENSATION,)VISION)BLURRED
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
DISCOMFORT,)VISION)BLURRED
OTHER)SERIOUS)(IMPORTANT)MEDICAL)EVENTS)
EYE)SWELLING,)PRURITUS,)ERYTHEMA
VISITED)A)HEALTH)CARE)PROVIDER,)OTHER)SERIOUS)(IMPORTANT)MEDICA
BURNING)SENSATION,)LACRIMATION)INCREASED,)HYPERSEN

 IRRITATION,)SWELLING,)CONJUNCTIVITIS,)HYPERSENSITIVITY
ERATOCONJUNCTIVITIS)SICCA

NSITIVITY,)INFLAMMATION,)EYE)SWELLING,)HYPERSENSITIVITY,)OCULAR)HYPERAEMIA,)MADAROSIS,)EYE)PRURITUS,)ERYTHEMA

PTIC)NERVE)INJURY
ION,)KERATITIS,)DISCOMFORT
,)RETINAL)DISORDER,)EYE)DISORDER,)BLINDNESS
WELLING,)VISION)BLURRED
URN)OF)SKIN,)SCAR,)IMPAIRED)WORK)ABILITY,)AGITATION,)EYE)INFLAMMATION
YPERAEMIA,)EYE)PAIN,)TENDERNESS,)BURNING)SENSATION,)EYE)SWELLING,)FOREIGN)BODY)IN)EYE,)BLINDNESS

BODY)TRAUMA
EMIA,)SWELLING

UID)RETENTION
,)ACNE,)SKIN)EXFOLIATION
JURY,)EYE)SWELLING,)LACRIMATION)INCREASED,)OCULAR)HYPERAEMIA,)EYE)DISCHARGE
PAIN,)EYE)IRRITATION
NG,)SWELLING,)EYE)PRURITUS
NG,)SWELLING,)EYE)PRURITUS
N,)HYPERSENSITIVITY,)ORAL)DISCOMFORT,)DERMATITIS,)CHEMICAL)BURN)OF)SKIN
EMIA,)HYPERSENSITIVITY
ON,)EYE)SWELLING
RRED,)LYMPHADENOPATHY,)BURNING)SENSATION,)RASH

SENSATION,)HYPERSENSITIVITY
LLING,)EYE)PRURITUS

PERAEMIA,)EYE)DISCHARGE
NG,)FACE)OEDEMA
EYE)PRURITUS,)OCULAR)HYPERAEMIA

ITATION,)INFLAMMATION
CYST,)BLOOD)TESTOSTERONE)INCREASED
D,)BURNING)SENSATION,)PAIN,)BURNING)SENSATION,)LACRIMATION)INCREASED,)DECREASED)APPETITE

N,)SWELLING
ITUS,)OCULAR)HYPERAEMIA,)EYE)INFECTION

 ELID,)PHOTOPHOBIA
PAIN,)LACRIMATION)INCREASED

N)BLURRED

IMATION)INCREASED,)HYPERSENSITIVITY,)ALLERGY)TEST)POSITIVE