UNK_MONOFOCAL IOL

Additional Manufacturer Narrative

SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/ REPLACED IN THE INITIAL SURGERY. (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE NON PRELOADED INTRAOCULAR LENSES(IOLS) WERE FOUND DAMAGED INSIDE THE CARTRIDGES, RENDERING THEM UNABLE TO BE INJECTED AND REQUIRING REPLACEMENT WITH NEW LENSES. ALL AFFECTED CARTRIDGES WERE IDENTIFIED AS BELONGING TO THE SAME LOT. IT WAS NOTED THAT THE DAMAGE OCCURRED WHILE THE LENSES WERE FULLY INSIDE THE CARTRIDGES, WITH NO CONTACT MADE BETWEEN THE LENSES AND THE PATIENTS' EYES, RESULTING IN NO ADVERSE EFFECTS FOR THE PATIENTS. ADDITIONAL INFORMATION INDICATED THAT A CRACK IN THE CARTRIDGE HAD FALLEN ONTO THE IOL AFTER IMPLANTATION AND THE TIP OF THE CARTRIDGE HAD BEEN BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINED TO ONE OF THE THREE LENSES.