BALANCED SALT SOLUTION

Description of Event or Problem

IT WAS REPORTED THAT THE DOCTOR PERFORMED A VITRECTOMY PROCEDURE ON (B)(64) 2012, USING ENDOSOL, BALANCED SALT SOLUTION. IT WAS STATED THAT THE PATIENT PRESENTED WITH SWELLING AND TOXIC SYNDROME ON THE ANTERIOR SEGMENT OF THE EYE. IT WAS REPORTED BY THE DOCTOR THAT ENDOSOL WAS INVOLVED, ALTHOUGH THE DOCTOR DID NOT THINK THAT THE ENDOSOL IS THE REASON FOR THE ADVERSE EVENT. THE PATIENT WAS TREATED MEDICALLY AND REPORTEDLY RECOVERED. INITIALLY, THE DOCTOR REPORTED TO ABBOTT MEDICAL OPTICS (AMO) THAT THE PATIENT WAS OK; HOWEVER, IT WAS LATER REPORTED THAT THE PATIENT HAD A ''LOSS OF VISION AND A LONG RECOVERY PROCESS WITH SERIOUS RISK INVOLVED.' NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF SUBMITTING THE MEDICAL DEVICE REPORT.

Additional Manufacturer Narrative

(B)(6). (B)(4). PRIOR TO RELEASE TO MARKET, THE ENDOSOL MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

Additional Manufacturer Narrative

CORRECTED DATA: (B)(6) 2012. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

Additional Manufacturer Narrative

EVALUATION OF THE RETURNED SAMPLES OF AMO ENDOSOL DEMONSTRATES THAT THE PRODUCT MET SPECIFICATIONS AND RELEASE REQUIREMENTS. (B)(4) - THE MANUFACTURING RECORD REVIEW INDICATED THAT THE BATCH PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.