ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
Report
- Report Number
- 1119421-2025-01261
- Event Type
- Injury
- Date Received
- May 2, 2025
- Report Date
- November 10, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- MFK
- UDI-DI
- 00380652389341
- PMA / PMN Number
- P040020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (TFNT30-60) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P040020). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION WAS PROVIDED IN H.11. THE FACILITY RETURNED THE WRONG IOL (INTRAOCULAR LENS). THE RETUNED LENS WAS NOT AN COMPANY PRODUCT. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE LENS HAS NOT BEEN RETURNED. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION WAS PROVIDED THAT THE COMPANY (1.00CYL), 16.0 DIOPTER (ADD POWER +2.2/+3.2) LENS WAS REPLACED WITH AN UNSPECIFIED LENS MODEL ON MAY 3, 2022. THE FACILITY PROVIDED THE INFORMATION THAT THE LENS FROM THE OTHER COMPANY WAS NOT RELATED TO THIS CASE. IT HAS BEEN CONFIRMED THAT THE ISSUE RESULTED FROM A MISTAKE MADE BY THE HOSPITAL STAFF WHEN PROVIDING THE DEFECTIVE LENS, THEY ACCIDENTALLY SENT THE WRONG ONE. THE FACILITY RETURNED THE WRONG IOL. THE RETUNED LENS WAS NOT AN COMPANY PRODUCT. THE FILE WILL BE REOPENED IF THE CORRECT LENS IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE LENS WAS RETURNED FOR EVALUATION. SOLUTION IS DRIED ON THE LENS. THE LENS IS CUT IN HALF, TYPICAL OF INSERTION AND REMOVAL FROM THE EYE. BOTH HALVES ARE ADHERED TO EACH OTHER BY SOLUTION. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION REGARDING THE REPLACEMENT LENS WAS NOT PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT COMPLAINT OF DISCOMFORT. THE IOL WAS REPLACED WITH UNSPECIFIED LENS AFTER INITIAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194447 | ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL | LENS, MULTIFOCAL INTRAOCULAR | MFK | ALCON RESEARCH, LLC - HUNTINGTON | TFNT20 | 12743691 | 00380652389341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |