GRIESHABER PIC DSP

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.11. NO LOT NUMBER WAS IDENTIFIED WITHIN THE SURVEY AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. SINCE THE QUESTIONNAIRE RETROSPECTIVELY COLLECTED DATA, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. THE EXACT ROOT CAUSE FOR THE CUSTOMER¿S REPORTED EVENT IS UNKNOWN. THEREFORE, NO SPECIFIC ACTION CAN BE TAKEN. AN OVERALL RISK ASSESSMENT WAS PERFORMED AND CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED. ADDITIONALLY, COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ADVERSE TRENDS. NO ADDITIONAL ACTIONS ARE NEEDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW-UP STUDY INDICATED THAT THE PATIENT UNDERWENT A VITREO RETINAL PROCEDURE IN THE EYE (UNKNOWN) USING AN OPHTHALMIC FLEX LOOP, SPATULA AND PIC TO IMPROVE THE CURRENT VISION. THE SURGERY WAS COMPLETED ON THE SAME DAY. LESS THAN ONE-MONTH POST-SURGERY THE PATIENT EXPERIENCED VITREOUS CAVITY INFLAMMATION, RETINAL HEMORRHAGE AND VITREOUS HEMORRHAGE. THE PATIENT WAS TREATED WITH LOCAL ANTI-INFLAMMATORY EYE DROPS AND ORAL HEMOSTATIC DRUGS AS AN INTERVENTION. THE CURRENT CONDITION OF THE PATIENT WAS IMPROVING GRADUALLY AND THE PATIENT WAS FOUND TO HAVE MILD INFLAMMATION AND VITREOUS HEMORRHAGE WITHOUT ANY ADVERSE CONSEQUENCES. NO FURTHER FOLLOW UP WILL BE CONDUCTED.