UNKNOWN

Description of Event or Problem

IT WAS REPORTED THAT AN UNKNOWN INTRAOCULAR LENS (IOL) WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE FOR AN UNSPECIFIED REASON. ADDITIONALLY, UNPLANNED SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D1: BRAND NAME: THE MODEL OF THE INTRAOCULAR LENS IS UNKNOWN. JOHNSON AND JOHNSON (JNJ)ASKED FOR DETAILS, BUT THE CUSTOMER COULD NOT PROVIDE. SINCE THE SURGEON MAY HAVE USED ANY ONE OF OUR JNJ INTRAOCULAR LENS, THEN THIS EVENT WAS REPORTED TO THE FDA IN ABUNDANCE OF CAUTION. SECTION D2A:COMMON DEVICE NAME: UNKNOWN/NOT PROVIDED. SECTION D2B: DEVICE PRODUCT CODE: UNKNOWN/NOT PROVIDED. SECTION D4: MODEL AND CATALOG NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER: A PARTIAL UDI WAS PROVIDED AS THE SERIAL NUMBER IS NOT AVAILABLE. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/INFORMATION NOT PROVIDED. SECTION E1: LAST NAME: UNKNOWN/INFORMATION NOT PROVIDED. SECTION G4: PMA/510(K) NUMBER: UNKNOWN DUE TO THE MODEL OR SERIAL NUMBER WERE NOT PROVIDED. JOHNSON AND JOHNSON (JNJ)ASKED FOR DETAILS BUT THE CUSTOMER COULD NOT PROVIDE. SINCE THE SURGEON MAY HAVE USED ANY ONE OF OUR JNJ INTRAOCULAR LENS, THEN THIS EVENT WAS REPORTED TO THE FDA IN ABUNDANCE OF CAUTION. 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 THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6: HEALTH EFFECT-IMPACT CODE 4625: ADDITIONAL SURGERY (PT-SUTURE). AN ATTEMPTS HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.