VERION DIGITAL MARKER M VLYNK

Additional Manufacturer Narrative

H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A LITERATURE CAPARISON STUDY WAS CONDUCTED IN TWO GROUPS OF PATIENTS FOR ASTIGMATISM CORRECTION. A PHYSICIAN REPORTED THAT POSTOPERATIVE VISUAL DISTURBANCE AND COMPLICATIONS, SEVEN PATIENTS IN ONE GROUP REPORTED PERSISTENT POSTOPERATIVE PHOTIC PHENOMENA AND IN OTHER GROUP ONLY ONE PATIENT EXPERIENCED THE SAME SYMPTOM, SIXTEEN PATIENTS IN ONE GROUP AND FOURTEEN PATIENTS IN THE OTHER GROUP REPORTED MILD POSTOPERATIVE PAIN, WHICH SUBSIDED WITHIN ONE WEEK WITH THE USE OF ANALGESICS IN UNKNOWN EYE AFTER CATARACT SURGERY.

Additional Manufacturer Narrative

CORRECTED INFORMATION PROVIDED IN H.2., H.11. UPON INTERNAL REVIEW OF THE FILE, IT WAS DETERMINED THAT PATIENT EXPERIENCED MILD POST OPERATIVE PAIN SUBSIDED AFTER USING ANALGESICS AND PHOTIC PHENOMENA AFTER SURGERY IN UNKNOWN EYE OF THE PATIENT DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS AS THERE WERE NO PRE-OPERATIVE AND POST-OPERATIVE REFRACTIVE OUTCOMES PROVIDED. THERE IS NO EVIDENCE OF A LIFE-THREATENING INJURY/ILLNESS OR PERMANENT IMPAIRMENT/DAMAGE, THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT/DAMAGE, AND THE INFORMATION PROVIDED DOES NOT REPRESENT A PRODUCT PROBLEM THAT IS LIKELY TO CAUSE THE ABOVE-MENTIONED EVENTS IF THE PRODUCT PROBLEM WERE TO RECUR. HENCE, THE FILE WILL BE RETAINED, WITH NO REGULATORY REPORTS REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.3., AND H.11. UPON FURTHER INVESTIGATION OF THE AVAILABLE INFORMATION, IT WAS CONCLUDED THAT DEVICE HAS NOT CONTRIBUTED TO ANY EVENTS, THE FILE WILL BE CLOSED AND NO FURTHER REPORTS ARE EXPECTED WITH MDR 3010300699-2025-00003. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.