FDA.reportPublic FDA data

MAUDE MDR 24954

MDR report key
24954
Report number
MW4000690
Event key
0
Event type
3
Date of event
1995-05-13
Date received
1995-08-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLASTIC SPECTACLE LENSSPECTACLE LENSROSIN OPTICAL CO.HQYN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-08-250

Event Narratives#

D

Patient 1

RPTR RECEIVED THE PAIR OF GLASSES VIA UPS OVERNIGHT ON 5/13/95, PUT THEM ON AND ADJUSTED THEM ON HER NOSE BY TOUCHING THEM AT THE TEMPLE. SHE SAID THAT ONE OF THE LENSES PARTIALLY SHATTERED AND A "V" SHAPED SHARD FLEW IN TO HER LEFT EYE, PIERCING HER CORNEA TRAVELLING ACROSS IT AND INJURING HER PUPIL. SHE HAD HER EYE DOCTOR REMOVE THE SHARD, AND SHE HAS PERMANENTLY LOST HER SIGHT IN THE EYE. SHE STATED THAT SHE REPORTED THE INCIDENT TO THE FIRM AND THEY TOLD HER THEY WERE NOT GOING TO REPORT IT TO THE FDA.