RAYONE GALAXY
Report
- Report Number
- 3012304651-2025-00321
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- October 14, 2025
- Report Date
- February 3, 2026
- Manufacturer
- RAYNER INTRAOCULAR LENSES LIMITED
- Product Code
- HQL
- UDI-DI
- 00502986700535
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REFERENCE C25-2091 HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING IMPLANTATION. THE IOL WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION. THERE WAS A PRIOR INCIDENT OF THE SAME NATURE OCCURING WITHIN THE SAME SURGERY SESSION WITH THE FIRST LENS (SEE FDA MDR 3012304651-2025-00320). A THIRD LENS WAS PREPARED AND IMPLANTED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE DEVICE WAS NOT AVAILABLE FOR RETURN TO RAYNER. THE RAYONE PRELOADED IOL INJECTION SYSTEM USE RISK ANALYSIS IDENTIFIES THE FOLLOWING AS POSSIBLE CAUSES OF "TRAPPED/ TORN LENS HAPTIC/ OPTIC DURING INSERTION"; INADEQUATE AMOUNT OF VISCOELASTIC; INADEQUATE QUALITY OF VISCOELASTIC; HAPTIC TRAPPED BY PLUNGER OVERRIDE DUE TO FAST MOTION; USER OPENS CLOSED FLAPS AND CLOSES AGAIN BEFORE USE; PLUNGER ADVANCED TOO QUICKLY, INSERTION OF VISCOELASTIC THROUGH NOZZLE LEADING TO INADEQUATE AMOUNT OF VISCOELASTIC; USER REMOVED INJECTOR FROM TRAY PRIOR TO INSERTING VISCOELASTIC, CAUSING LENS TO BE IMPROPERLY PLACED IN CARTRIDGE; USER REMOVED INJECTOR FROM TRAY PRIOR TO CLOSING CARTRIDGE, RESULTING IN CARTRIDGE NOT BEING CLIPPED PROPERLY; OPTIC EDGE TRAPPED/ DAMAGED ON CLOSURE OF CARTRIDGE, SHARP EDGE INSTRUMENTS AND DEHYDRATION OF THE LENS PRIOR TO IMPLANTATION. THE ADDITIONAL INFORMATION RECEIVED IDENTIFIES THAT THE SURGEON ENCOUNTERED RESISTANCE AS THE LENS MOVED FROM THE CARTRIDGE TO THE NOZZLE. THE RAYONE IFU "USE OF RAYONE" SECTION "FIG 7" STATES "PRESS THE PLUNGER IN A SLOW AND CONTROLLED MANNER. IF EXCESSIVE RESISTANCE IS FELT THIS COULD INDICATE A BLOCKAGE; DISCONTINUE USE OF THE PRODUCT AND RETURN THE PRODUCT AND ALL PACKAGING TO RAYNER". OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY RAO605G BATCH 055268416 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. A REVIEW OF VIGILANCE DATA CONFIRMS THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE GALAXY RAO605G BATCH 055268416. THE DEVICE WAS RETAINED AND RETURNED TO RAYNER FOR EVALUATION. TWO INJECTORS AND TWO IOLS WERE RETURNED MIXED UP IN A SMALL BAG WITH NO IDENTIFICATION AND THEREFORE IT IS NOT POSSIBLE TO DISTINGUISH BETWEEN WHICH SAMPLE CORRESPONDS TO C25-2090, AND WHICH CORRESPONDS TO C25-2091. FOR THE PURPOSES OF PRODUCT INSPECTION, THE EVALUATION WILL BE PERFORMED AS INJECTOR 1 AND INJECTOR 2. INJECTOR 1: PRELIMINARY INSPECTION OF THE RETURNED INJECTOR SHOWED THAT THE FLAPS WERE FULLY CLOSED, AND THAT THE PLUNGER WAS FULLY RETRACTED. VISCOELASTIC RESIDUE WAS OBSERVED IN THE NOZZLE. THE INJECTOR WAS DISASSEMBLED. THE INJECTOR PARTS WERE INSPECTED UNDER 10X MAGNIFICATION. THE INSPECTION DID NOT IDENTIFY ANY DAMAGE TO INJECTOR PARTS. TO FACILITATE FURTHER TESTING OF THE INJECTOR, THE INJECTOR WAS RE-ASSEMBLED USING RAYONE ASPHERIC 600C FROM RAYNER STOCK AND A NEW PLUNGER AND WAS LOADED AND INJECTED AS PER THE IFU. OPHTEISBIO3.0% OVD WAS USED. INJECTION WAS SUCCESSFUL, WITH NO RESISTANCE EXPERIENCED, AND WITH NO DAMAGE TO THE LENS OR INJECTOR POST INJECTION. A TOLUIDINE BLUE 0.5% DYE TEST WAS PERFORMED ON THE NOZZLE. THIS TEST DID NOT IDENTIFY ANY IRREGULARITY IN THE NOZZLE COATING. ROOT CAUSE OF THE REPORTED FAULT COULD NOT BE ESTABLISHED. ON PRODUCT RETURN INSPECTION AND TESTING COMPLETED, NO RAYONE INJECTOR FAULT WAS FOUND. RESULTS OF INJECTOR TESTING CONFIRM THAT THE DEVICE PERFORMS AS INTENDED/ PER DESIGN. INJECTOR 2: PRELIMINARY INSPECTION OF THE RETURNED INJECTOR SHOWED THAT THE FLAPS WERE FULLY CLOSED, AND THAT THE PLUNGER WAS FULLY RETRACTED. VISCOELASTIC RESIDUE WAS OBSERVED IN THE NOZZLE. THE INJECTOR WAS DISASSEMBLED. THE INJECTOR PARTS WERE INSPECTED UNDER 10X MAGNIFICATION. THE INSPECTION DID NOT IDENTIFY ANY DAMAGE TO INJECTOR PARTS. TO FACILITATE FURTHER TESTING OF THE INJECTOR, THE INJECTOR WAS RE-ASSEMBLED USING RAYONE ASPHERIC 600C FROM RAYNER STOCK AND A NEW PLUNGER AND WAS LOADED AND INJECTED AS PER THE IFU. OPHTEISBIO3.0% OVD WAS USED. INJECTION WAS SUCCESSFUL, WITH NO RESISTANCE EXPERIENCED, AND WITH NO DAMAGE TO THE LENS OR INJECTOR POST INJECTION. A TOLUIDINE BLUE 0.5% DYE TEST WAS PERFORMED ON THE NOZZLE. THIS TEST DID NOT IDENTIFY ANY IRREGULARITY IN THE NOZZLE COATING. ROOT CAUSE OF THE REPORTED FAULT COULD NOT BE ESTABLISHED. ON PRODUCT RETURN INSPECTION AND TESTING COMPLETED, NO RAYONE INJECTOR FAULT WAS FOUND. RESULTS OF INJECTOR TESTING CONFIRM THAT THE DEVICE PERFORMS AS INTENDED/PER DESIGN. INVESTIGATION FOUND NO FAULT OF THE RAYNER DEVICE. CAUSE TRACED TO NON-DEVICE RELATED FACTORS.
THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING IMPLANTATION. THE IOL WAS EXPLANTED AND EXCHANGED DURING THE ORIGINAL SURGERY SESSION. THERE WAS A PRIOR INCIDENT OF THE SAME NATURE OCCURING WITHIN THE SAME SURGERY SESSION WITH THE FIRST LENS (SEE FDA MDR 3012304651-2025-00320). A THIRD LENS WAS PREPARED AND IMPLANTED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE DEVICE WAS NOT AVAILABLE FOR RETURN TO RAYNER. THE RAYONE PRELOADED IOL INJECTION SYSTEM USE RISK ANALYSIS IDENTIFIES THE FOLLOWING AS POSSIBLE CAUSES OF "TRAPPED/ TORN LENS HAPTIC/ OPTIC DURING INSERTION"; INADEQUATE AMOUNT OF VISCOELASTIC; INADEQUATE QUALITY OF VISCOELASTIC; HAPTIC TRAPPED BY PLUNGER OVERRIDE DUE TO FAST MOTION; USER OPENS CLOSED FLAPS AND CLOSES AGAIN BEFORE USE; PLUNGER ADVANCED TOO QUICKLY, INSERTION OF VISCOELASTIC THROUGH NOZZLE LEADING TO INADEQUATE AMOUNT OF VISCOELASTIC; USER REMOVED INJECTOR FROM TRAY PRIOR TO INSERTING VISCOELASTIC, CAUSING LENS TO BE IMPROPERLY PLACED IN CARTRIDGE; USER REMOVED INJECTOR FROM TRAY PRIOR TO CLOSING CARTRIDGE, RESULTING IN CARTRIDGE NOT BEING CLIPPED PROPERLY; OPTIC EDGE TRAPPED/ DAMAGED ON CLOSURE OF CARTRIDGE, SHARP EDGE INSTRUMENTS AND DEHYDRATION OF THE LENS PRIOR TO IMPLANTATION. THE ADDITIONAL INFORMATION RECEIVED IDENTIFIES THAT THE SURGEON ENCOUNTERED RESISTANCE AS THE LENS MOVED FROM THE CARTRIDGE TO THE NOZZLE. THE RAYONE IFU "USE OF RAYONE" SECTION "FIG 7" STATES "PRESS THE PLUNGER IN A SLOW AND CONTROLLED MANNER. IF EXCESSIVE RESISTANCE IS FELT THIS COULD INDICATE A BLOCKAGE; DISCONTINUE USE OF THE PRODUCT AND RETURN THE PRODUCT AND ALL PACKAGING TO RAYNER". OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE GALAXY RAO605G BATCH: 055268416 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. A REVIEW OF VIGILANCE DATA CONFIRMS THIS IS AN ISOLATED EVENT. NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE GALAXY RAO605G BATCH: 055268416. WITHOUT THE ABILITY TO EXAMINE THE DEVICE AND WITHOUT CLEAR EVENT DETAILS BEING PROVIDED IT IS NOT POSSIBLE TO ESTABLISH THE CAUSE OF THE EVENT.
ON 14TH OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN BRAZIL OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING IMPLANTATION NECESSITATING LENS EXPLANTATION AND EXCHANGE.
ON 14TH OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM A HEALTHCARE FACILITY IN BRAZIL OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE GALAXY RAO605G. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS WAS TORN DURING IMPLANTATION NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2719944 | RAYONE GALAXY | RAYONE GALAXY | HQL | RAYNER INTRAOCULAR LENSES LIMITED | RAO605G | 055268416 | 00502986700535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |