UNK_MONOFOCAL IOL

Additional Manufacturer Narrative

SECTION A2 AGE OR DATE OF BIRTH: UNKNOWN/NOT PROVIDED. SECTION A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: UNKNOWN/NOT PROVIDED. SECTION B3, DATE OF EVENT: UNKNOWN, NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS REMAINS IMPLANTED. SECTION D1, BRAND NAME: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN SERIAL NUMBER. SECTION D4, MODEL AND CATALOG NUMBER: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN SERIAL NUMBER. SECTION D4, SERIAL NUMBER: UNKNOWN/NO INFORMATION 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 H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT STATED THAT FOR OVER A YEAR HE HAS COMPLAINED TO HIS DOCTOR ABOUT WHAT HE DESCRIBES AS A STAIN OR SPOT ON THE IMPLANTED LENS, WHICH HE BELIEVES IS CAUSING EXCESSIVE BLURRY VISION. ACCORDING TO THE PATIENT, HIS DOCTOR ADVISED THAT THE ISSUE WOULD RESOLVE OVER TIME. HOWEVER, THE SYMPTOMS HAVE PERSISTED FOR MORE THAN A YEAR WITHOUT IMPROVEMENT. THE PATIENT FURTHER STATED THAT HIS DOCTOR ATTRIBUTED THE BLURRY VISION TO INFLAMMATION. IN ADDITION TO THE VISUAL SYMPTOMS, THE PATIENT REPORTED EXPERIENCING PAIN IN THE AFFECTED EYE AND FEELS THAT ON THE EDGE OF THIS EYE THE LENS IS CUTTING INTO THIS EYELID WHICH CAUSES DISCOMFORT. NO FURTHER INFORMATION IS AVAILABLE.