PERFLUORON
Report
- Report Number
- 1610287-2026-00011
- Event Type
- Injury
- Date Received
- March 7, 2026
- Report Date
- May 4, 2026
- Manufacturer
- ALCON RESEARCH, LLC
- Product Code
- LWL
- PMA / PMN Number
- P950018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. LITERATURE CITATION: MCKAY BR, BANSAL A, KRYSHTALSKYJ M, ET AL, TWO- YEAR OUTCOMES OF DIFFERENT SUBRETINAL FLUID DRAINAGE TECHNIQUES DURING VITRECTOMY FOR FOVEA- OFF RHEGMATOGENOUS RETINAL DETACHMENTS: ELLIPSOID- 2 STUDY. BR J OPHTHALMOL. 2024; 108:1263¿1268. 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 INFORMATION WAS PROVIDED IN SECTIONS H.6. AND H.11. NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. -SOLUTION QUALITY ISSUE ¿ UNLIKELY; CHEMISTRY AND MICRO DATA FOR THIS LOT WAS REVIEWED AND WAS FOUND TO HAVE MET RELEASE CRITERIA. - NONCONFORMING COMPONENTS¿ UNLIKELY, INCOMING COMPONENT INSPECTION RESULTS INDICATE THE COMPONENTS USED WAS ACCEPTABLE. -CONSUMER MISHANDLING - NO CONCLUSION CAN BE MADE AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. -EVENT RELATED TO SURGICAL TECHNIQUE ¿ NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF SURGICAL TECHNIQUE. -EVENT RELATED TO CONSUMER PHYSIOLOGY ¿ NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF UNIQUE CONSUMER PHYSIOLOGY AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. NO LOT CODE WAS REPORTED OR SAMPLE PROVIDED BY THE CUSTOMER. NO FURTHER ACTION IS POSSIBLE AT THIS TIME. PER MONTHLY TRENDING, ASSOCIATED TREND ALERT WAS OBSERVED. NO ACTIONS ARE REQUIRED AT THIS TIME. ALL COMPLAINT TRENDS ARE REVIEWED ON A MONTHLY BASIS, AND CORRECTIVE ACTIONS WILL BE DEFINED IF 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.
CORRECTED INFORMATION WAS PROVIDED IN SECTION G.2. 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.
A LITERATURE STUDY WAS CONDUCTED ON 300 CONSECUTIVE PATIENTS WITH PRIMARY RHEGMATOGENOUS RETINAL DETACHMENTS (RRDS) UNDERGOING 23 GAUGE PARS PLANA VITRECTOMY WITH SUBRETINAL FLUID DRAINAGE TO COMPARE VISUAL ACUITY, COMPLICATIONS, AND OUTER RETINAL INTEGRITY FOLLOWING SUBRETINAL FLUID DRAINAGE FROM THE PERIPHERAL RETINAL BREAKS (PRBS) GROUP VERSUS THE POSTERIOR RETINOTOMY (PR) GROUP VERSUS THE PERFLUOROCARBON LIQUID (PFCL) GROUP FOR MACULA OFF RHEGMATOGENOUS RETINAL DETACHMENTS (RRDS). ONE HUNDRED PATIENTS WERE TREATED WITH PERFLUOROCARBON LIQUIDS (PFCL). ONE PERCENT OF PATIENTS HAD EVIDENCE OF SMALL SUBRETINAL PERFLUOROCARBON LIQUID (PFCL) OUTSIDE THE MACULAR CUBE ON OPTICAL COHERENCE TOMOGRAPHY (OCT). THESE PATIENTS WERE MONITORED AND DID NOT REQUIRE REOPERATION. THIS REPORT PERTAINS TO THREE OF SEVEN REPORTS FROM THE SAME STUDY. LITERATURE CITATION: MCKAY BR, BANSAL A, KRYSHTALSKYJ M, ET AL, TWO- YEAR OUTCOMES OF DIFFERENT SUBRETINAL FLUID DRAINAGE TECHNIQUES DURING VITRECTOMY FOR FOVEA- OFF RHEGMATOGENOUS RETINAL DETACHMENTS: ELLIPSOID- 2 STUDY. BR J OPHTHALMOL. 2024;108:1263¿1268.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474124 | PERFLUORON | FLUID, INTRAOCULAR | LWL | ALCON RESEARCH, LLC | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |