FDA.reportPublic FDA data

MAUDE MDR 33722

MDR report key
33722
Report number
MW1009375
Event key
0
Event type
3
Date of event
1996-06-12
Date received
1996-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
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
1SURGILENSCORNEAL SHIELDCHIRON CORP.MOENANAQ2Q796ANN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-06-250

Event Narratives#

D

Patient 1

DURING SURGERY THE CIRCULATING NURSE WAS ASKED TO GIVE TOBRADEX ON THE CORNEAL SHIELD. AT THIS TIME THE SCRUB TECH NOTICED IRREGULAR EDGES ON THE SHIELD. AFTER A CLOSER LOOK RPTR NOTICED A LARGE PORTION MISSING FROM THE EDGE. THE SURGEON REJECTED THE LENS AND ANOTHER ONE WAS OPENED AND REPLACED.