ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
Report
- Report Number
- 1119421-2024-01331
- Event Type
- Malfunction
- Date Received
- July 16, 2024
- Report Date
- September 27, 2024
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652422901
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION WAS PROVIDED IN B.5., B.6. AND H.11. 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 (DFT315-615) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P930014).¿ THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ON INITIAL MDR THE EVALUATION PRODUCT CODE OF A27 WAS AN ERROR. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. A QUALIFIED CARTRIDGE AND HANDPIECE WERE USED WITH A NON-QUALIFIED VISCOELASTIC. THE ROOT CAUSE FOR THE REPORTED "FOLDING PRINT-DEFECT ON OPTIC" MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU. A NON-QUALIFIED VISCOELASTIC WAS INDICATED. THE IFU(INSTRUCTIONS FOR USE) INSTRUCTS: COMPANY FOLDABLE IOLS ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE IFU INSTRUCTS: USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. INFORMATION WAS PROVIDED THAT INDICATED THE MARK HAD THE WIDTH OF THE PLUNGER. PHOTOS WERE NOT AVAILABLE FOR VERIFICATION. THIS DESCRIPTION MAY INDICATE THE LENS WAS DAMAGED BY THE HANDPIECE PLUNGER OVERRIDING THE LENS DURING THE DELIVERY. THE HANDPIECE IFU INSTRUCTS: IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT COMPANY. VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY HALF TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL (INTRAOCULAR LENS) WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. FILE WILL BE REOPENED IF NEW INFORMATION OR THE SAMPLE IS RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCING THE SCATTERED LIGHT, SEES A KIND OF HALF-CIRCLES AT THE BOTTOM OF THE VISION. THE ONLY THING THAT STANDS OUT IS THAT THERE IS A KIND OF GLISTENING DIAGONALLY IN THE LENS, DIAGONALLY THROUGH THE OPTICAL AXIS. THE PHYSICIAN ALSO STATED FOLDING PRINT WAS OBSERVED AND WHICH SHOULD DISAPPEAR ON ITS OWN. THE PRINT LOOKS LIKE TWEEZERS PRINT, WHICH WAS A STRANGE, HOWEVER THE PHYSICIAN ALSO MENTIONED THAT, HE GRABBED THE LENS BY THE HAPTICS WITH TWEEZERS. WHEN PATIENT LOOKS WITH BOTH EYES HE HAS NO COMPLAINTS.
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THEY SAW THE STRIPE ON THE OPTIC, SUPERFICIAL AT THE FRONT, METALLIC PARTICLES / GLITTERING SUPERFICIAL STRIPE, WIDTH EXACTLY LIKE THAT OF THE PLUNGER OF THE COMPANY INJECTOR, IT SEEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2505029 | ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL | INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | DFT215 | 15335372 | 00380652422901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | MC PHERSON LENS IOL FORCEPS, HASA OPTIX| MONARCH CARTRIDGE D| MONARCH INJECTOR| PROTECTALON 1.4%, |