VERION DIGITAL MARKER M

Additional Manufacturer Narrative

EVALUATION SUMMARY: NO SAMPLE IS EXPECTED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE COULD NOT BE PERFORMED, AS THE SERIAL NUMBER WAS NOT PROVIDED BY THE REPORTER. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

Description of Event or Problem

AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING TORIC INTRAOCULAR LENS (IOL) IMPLANT SURGERY, FOUR PATIENTS HAD AN EXPECTED REFRACTIVE OUTCOME. ALL FOUR PATIENTS WERE MEASURED PREOPERATIVELY WITH THE REFERENCE UNIT. THE OUTCOME WAS DUE TO THE POSITIONING OF THE IOL AXIS BEING TEN TO FIFTEEN DEGREES AWAY FROM THE INTENDED POSITION. THERE WERE NO SPECIFIC PATIENT IDENTIFIERS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN A.1., B.5., H.3., H.6., AND H.10. CORRECTED INFORMATION PROVIDED IN B.1., B.3., D.1., D.2., D.4., D.6., E.1., AND H.1. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD, PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. A WRONG REGISTRATION PROPOSAL WAS CONFIRMED BY THE USER. REPORTED EVENT RESULTED FROM THE FAILURE OF THE CUSTOMER TO FOLLOW PUBLISHED INSTRUCTIONS FOR USE.

Description of Event or Problem

IN A FOLLOW UP ONE, THE OPHTHALMOLOGIST REPORTED THAT FOR THE FIRST PATIENT OF THE SURGICAL DAY, THE PLANNED AXIS WAS PLANNED AT 180 DEGREES, YET IT WAS AT 25 DEGREES. THERE ARE FOUR REPORTS ASSOCIATED WITH THIS EVENT. ADDITIONAL REPORTS WILL BE FILED FOR THE REMAINING PATIENTS.

Additional Manufacturer Narrative

CORRECTED INFORMATION PROVIDED IN B.1, B.3, D.1, D.2, D.4, D.6, E.1. AND H.1. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD; PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. A WRONG REGISTRATION PROPOSAL WAS CONFIRMED BY THE USER. REPORTED EVENT RESULTED FROM THE FAILURE OF THE CUSTOMER TO FOLLOW PUBLISHED INSTRUCTIONS FOR USE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING TORIC INTRAOCULAR LENS (IOL) IMPLANT SURGERY, FOUR PATIENTS HAD AN EXPECTED REFRACTIVE OUTCOME. ALL FOUR PATIENTS WERE MEASURED PREOPERATIVELY WITH THE REFERENCE UNIT. THE OUTCOME WAS DUE TO THE POSITIONING OF THE IOL AXIS BEING TEN TO FIFTEEN DEGREES AWAY FROM THE INTENDED POSITION. THERE WERE NO SPECIFIC PATIENT IDENTIFIERS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IN A FOLLOW UP, THE OPHTHALMOLOGIST REPORTED THAT FOR THE FIRST PATIENT OF THE SURGICAL DAY, THE PLANNED AXIS WAS PLANNED AT 180 DEGREES, YET IT WAS AT 25 DEGREES. THERE ARE FOUR REPORTS ASSOCIATED WITH THIS EVENT. ADDITIONAL REPORTS WILL BE FILED FOR THE REMAINING PATIENTS.

Additional Manufacturer Narrative

CORRECTION G.3: SUPPLEMENTAL MEDICAL DEVICE REPORT# 3 IS BEING FILED TO CORRECT THE G.3 DATE ON THE SUPPLEMENTAL REPORT#2, FILED EARLIER. THE G.3 DATE SHOULD BE 06-SEP-2024 INSTEAD OF 13-SEP-2016. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).