GRIESHABER DELAMINATION SPATULA DSP

Additional Manufacturer Narrative

PER THE INITIAL REPORT, THIS COMPLAINT IS ASSOCIATED WITH A POST-MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THAT WAS ASSESSED UNDER THE CORRESPONDING CLINICAL EVALUATION REPORT. THE PMCF STUDY FACILITATED A QUESTIONNAIRE, WHICH FOCUSED ON ASSESSING PROCEDURAL SUCCESS OF THE DEVICES UNDER EVALUATION. A NUMBER OF NEGATIVE RESPONSES (SUGGESTING DEVICE DEFICIENCIES AND/OR ADVERSE EVENTS) WAS RECEIVED, WHICH WAS TRANSLATED INTO COMPLAINTS. DUE TO THE NATURE OF THE QUESTIONNAIRE, INFORMATION REQUIRED TO PERFORM A PROPER COMPLAINT INVESTIGATION WAS NOT COLLECTED. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW-UP STUDY INDICATED THAT THE MALE PATIENT UNDERWENT A VITRO RETINAL PROCEDURE USING A DELAMINATION SPATULA AS A TREATMENT TO IMPROVE CURRENT VISION. THE PATIENT HAS EXPERIENCED HYPOTONY A MONTH AFTER THE SURGERY. CURRENT CONDITION OF PATIENT IS IMPROVING.