FDA Adverse Event Injury Summary report: N

STAAR

MDR report key: 304013 · Received November 7, 2000

Report

Report Number
MW4002889
Event Type
Injury
Date Received
November 7, 2000
Date of Event
January 14, 2000
Report Date
November 7, 2000
Manufacturer
STAAR SURGICAL CO
Product Code
HQL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NL
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

PT HAS A CATARACT OPERATION PERFORMED ON LEFT EYE AT CLINIC. FOUR MONTHS LATER PT'S RIGHT EYE OPERATED ON. DURING THESE SURGICAL PROCEDURES, WHICH WERE VIDEOTAPED AND WHICH PROGRESSED NORMALLY AND WITHOUT INCIDENT, "INTRAOCULAR LENSES MODEL AA4203VF WERE IMPLANTED. WITH REFERENCE TO THE SURGICAL PROCEDURE REGARDING LEFT EYE, A NUMBER OF POST-OPERATIVE PROBLEMS HAVE OCCURRED. ACCORDING TO EXPERTS, THE STRUCTURE OF THE LENS IS CHANGING, THE LENS IS, IN THE PROCESS, COLORING BROWN. IN ADDITION, THE MEMBRANE OF THE GLASS FLUIDS HAS COME LOOSE. THIS HAS BEEN CONCLUDED AND RECORDED ON PHOTOGRAPHIC FILM BY PT'S OWN OPHTHALMOLOGIST. FINDINGS WERE CONFIRMED BY AT THE CLINIC. SIX MONTHS LATER PT HAD TO UNDERGO SURGERY BY ANOTHER DR BECAUSE OF AN ACUTE DISCHARGE OF THE RETINA. SPECIALISTS HAVE DECLARED THAT PT'S SIGHT IN LEFT EYE HAS DECREASED TO 60% IN THE PAST FEW MONTHS; THERE IS NO HOPE OF RECOVERING FULL SIGHT AGAIN. THE SERIES OF OPERATIONS HAS AS YET NOT ENDED; SPECIALISTS ARE NOW CONSIDERING THE RISKS OF AN ADD'L "VITRECTOMIA-OPERATION" AND, IN TIME, A REPLACEMENT OF THE LENS WITH A NEW ONE. THE RIGHT LENS, HOWEVER, HAS POSED NO PROBLEMS, THIS LEADS TO THE CONCLUSION THAT THE LENS THAT WAS IMPLANTED INTO THE LEFT EYE WAS OF AN INFERIOR QUALITY. RPTR INFORMED STAAR SURGICAL CO ABOUT THIS. THEY CONFIRMED THEY RECEIVED RPTR'S LETTER AND FORWARDED THE CASE TO THEIR LAWYERS LAST JUNE. IN SPITE OF THREE REMINDERS, RPTR HASN'T HEARD FROM THEM SINCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STAAR INTRAOCULAR LENS HQL STAAR SURGICAL CO AA4203VF NA

Patients

Seq Age Sex Outcome Treatment
1 NO INFO