IFS ADVANCED FEMTOSEC LASER
Received Nov 5, 2025 · Event occurred Jan 5, 2023
Report 3012236936-2025-000276 · MDR key 23482161
Device
Generic name
Powered Laser Surgical Instrument
Manufacturer
Amo Manufacturing Usa, LlcModel number
UNK-INTRALASECatalog number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Dry Eye(s)
- Blurred Vision
- Visual Impairment
- Visual Disturbances
- Distress
- Eye Pain
- Unspecified Eye / Vision Problem
- Dry Eye(s)
- Blurred Vision
- Visual Impairment
- Visual Disturbances
- Distress
- Eye Pain
- Unspecified Eye / Vision Problem
Narrative
Additional Manufacturer Narrative
CORRECTED INFORMATION: SECTION H6, ADVERSE EVENT OR PROBLEM: 4471, UNSPECIFIED EYE / VISION PROBLEM - REMOVED AND REPLACED WITH 2329, DISTRESS. 2137, BLURRED VISION, REMOVED AS THIS IS BEING COVERED UNDER CODE 2138 VISUAL IMPAIRMENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT POST LASIK SURGERY ON THE (B)(6) 2023, THEY HAVE EXPERIENCED BILATERAL GHOSTING WITH LEFT EYE (OS) MORE SEVERE, UNCORRECTABLE VISION, UNCORRECTABLE ASTIGMATISM, FLUCTUATING VISION, DRY EYES, VERTICAL LIGHT STREAKS WHEN BLINKING, PAIN WHEN EYES IN CONTACT WITH WATER (INCLUDING TEARS), INCREASED TEARS, AND SUICIDAL IDEATION. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D4 - CATALOGUE #, EXPIRATION DATE, UDI #, SERIAL #: UNKNOWN/NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE TO SUSPECT DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE TO SUSPECT DEVICE. SECTION E1 - ESTABLISHMENT NAME, ADDRESS, CITY AND POST OFFICE OR ZIP CODE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - ESTABLISHMENT NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE DEVICE IS UNKNOWN AND THUS, NOT AVAILABLE FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.