LABTICIAN RETINAL IMPLANT

Additional Manufacturer Narrative

LABTICIAN BELIEVES THAT THE LIKELIHOOD OF INFECTION ARISING FROM ITS ROUND SPONGE IS VERY LOW. ALTHOUGH IT IS IMPOSSIBLE TO RULE OUT (AT THIS TIME) LABTICIAN COMES TO THIS PRELIMINARY BELIEF: SIMILAR RELATED INFECTIONS DURING THE SAME MONTH NOT INVOLVING LABTICIAN MEDICAL DEVICES. INDICATION THAT INFECTION ALSO INVOLVED AREA INSIDE THE EYE WHEREAS THE LABTICIAN IMPLANT REMAINS OUTSIDE THE EYE. REVIEW OF DEVICE HISTORY RECORD REVEALED NO NONCONFORMANCES OR UNUSUAL ANOMALIES. LACK OF SIMILAR COMPLAINTS FOR THIS DEVICE LOT NUMBER. LACK OF SIMILAR COMPLAINT IN HISTORY OF RETINAL IMPLANT SALES (30 YEARS). NO CHANGES TO THE MANUFACTURING PROCESS INCLUDING STERILIZATION PROCESS; CONSISTENTLY LOW BIOBURDEN RESULTS (1.3 CFU - RECENT BIOBURDEN RESULT FOR THE PARTICULAR DEVICE). WE CONTINUE TO ENGAGE IN DIALOGUE WITH OUR DISTRIBUTOR WHO IS IN CONTACT WITH THE PHYSICIAN AND ARE CAREFULLY MONITORING CUSTOMER COMMUNICATIONS. IN ADDITION, WE HAVE SENT REPRESENTATIVE SAMPLES OF THIS DEVICE (WITH SAME LOT NUMBER AS THE DEVICE INVOLVED IN THE ADVERSE EVENT) TO A THIRD PARTY FOR PRODUCT STERILITY TESTING. THE RESULTS, ALONG WITH ANY ADDITIONAL INFORMATION OBTAINED, WILL BE FORWARDED TO THE FDA IN SUPPLEMENTAL REPORTS.

Description of Event or Problem

A CLINICIAN ((B)(6)) WHO WORKS AT UNIVERSITY (B)(6), INFORMED LABTICIAN'S DISTRIBUTOR (B)(4), THAT THREE PATIENTS INCURRED INFECTIONS FOLLOWING OPHTHALMIC PROCEDURES THAT TOOK PLACE BETWEEN THE DATES (B)(6) 2016 (EXACT DATES FOR EACH OF THE PATIENTS INVOLVED WERE NOT PROVIDED). THE PATIENTS INVOLVED (AND THEIR PARTICULAR SURGICAL PROCEDURE WERE AS FOLLOWS (AS REPORTED BY THE CLINICIAN): PATIENT 1: MALE, (B)(6); PROCEDURE: PLOMBE. PATIENT 2: FEMALE, (B)(6); PROCEDURE: CERCLAGE, SILICON OIL, ENDOLASER, PEELING, DECALINE, 20 GA PPV. PATIENT 3: FEMALE, (B)(6) PROCEDURE: PPV, CERCLAGE AND GAS. IN ADDITION TO THE 3 REPORTED CASES TO LABTICIAN, THE CLINICIAN REPORTED TO LABTICIAN THAT THERE HAVE BEEN OTHER INFECTIONS IN THE SAME MONTH (OF (B)(6)) THAT DID NOT INVOLVE ANY LABTICIAN PRODUCT - AND LOGICALLY WE WERE NOT CONTACTED FOR THOSE. AS A PRECAUTIONARY MEASURE THE CLINICIAN INFORMED ALL MANUFACTURERS OF MEDICAL DEVICES WHO WERE INVOLVED IN THE VARIOUS PROCEDURES - AND THIS INCLUDED LABTICIAN. IN ALL THREE CASES, LABTICIAN'S ROUND SPONGE - S1982-5 (LOT # 42385) WAS UTILIZED DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY LABTICIAN, HOWEVER BASED ON PRELIMINARY REQUESTS FOR DATA, THE CLINICIAN REPORTED THE TREATMENT OF THE PATIENTS AS (QUOTED): "PLOMBE AND CERGLACE DISTANCE, SYSTEMS AND LOCAL ANTIBIOSE, VITRECTOMY TRANSMIGRATION ENDOPHTHALMITIS, ANTIBIOTICS FLUSHING." THERE IS EVIDENCE TO SUGGEST HERE THAT THE INFECTION EITHER OCCURRED SOLELY FROM WITHIN THE EYE (ENDOPHTHALMITIS) OR POSSIBLY BOTH INSIDE AND OUTSIDE OF THE EYE. "ENDOPHTHALMITIS" IS AN INFECTION INSIDE THE EYEBALL (GLOBE). THE INSIDE OF THE EYE IS SEALED AND STERILE AND TYPICALLY NOT EXPOSED TO EXTERNAL ORGANISMS, SUCH AS BACTERIA OR FUNGUS. BECAUSE THE TISSUES WITHIN THE EYEBALL ARE VERY DELICATE, ENDOPHTHALMITIS IS VERY SERIOUS AND CAN LEAD TO BLINDNESS AND EVEN LOSS OF THE EYE ITSELF. ONE IMPORTANT NOTE REGARDING THE LABTICIAN ROUND SPONGE IS THAT IT IS USED OUTSIDE THE ACTUAL EYE .