PERFLUORON
Report
- Report Number
- 1610287-2026-00014
- Event Type
- Injury
- Date Received
- March 7, 2026
- Report Date
- May 29, 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
- 003
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.
NO PHOTO(S) AND/OR VIDEO(S) WAS PROVIDED BY THE REPORTER, AND A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT/BATCH/SERIAL NUMBER CANNOT BE PERFORMED AS THE LOT/BATCH/SERIAL NUMBER IS UNKNOWN. SPECIFIC PRODUCT IDENTIFIERS (BATCH/LOT/SERIAL NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, A REVIEW OF ALL MANUFACTURING BATCH RECORDS IS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE PRODUCT'S ACCEPTANCE CRITERIA. A REVIEW OF PRODUCTION INFORMATION, COMPLAINT HISTORY, AND SERVICING WAS NOT PERFORMED AS THE LOT/BATCH/SERIAL NUMBER IS UNKNOWN. A COMPLAINT SAMPLE, PHOTO, AND/OR VIDEO WAS NOT PROVIDED FOR EVALUATION. BASED ON THE INVESTIGATION, A FAILURE OF THE DEVICE, LABELING, OR PACKAGING TO MEET SPECIFICATIONS COULD NOT BE CONFIRMED. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A REEVALUATION OF THE COMPLAINT INVESTIGATION. MANUFACTURER QUALITY ASSURANCE HAS REVIEWED, EVALUATED AND INVESTIGATED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, IF APPROPRIATE. RECEIPT OF COMPLAINT SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT WILL RESULT IN RE-EVALUATION OF THE COMPLAINT INVESTIGATION. 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). SECONDARY OUTCOMES WERE DISCONTINUITY OF ELLIPSOID ZONE (EZ) AT 24 MONTHS POST- SURGERY IN FEW PATIENTS IN THE PERFLUOROCARBON LIQUID (PFCL) GROUP. THE DETAILS AND STATUS OF PATIENTS WERE UNKNOWN. THIS REPORT PERTAINS TO SIX 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 |
|---|---|---|---|---|---|---|---|
| 43598 | PERFLUORON | FLUID, INTRAOCULAR | LWL | ALCON RESEARCH, LLC | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |