MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-4 patient weight: unknown/asked information unavailable.Section a-5 patient race: unknown however, response provided was: white.Section b-3: date of event: unknown however, response provided was: (b)(6) 2024 (future date).The best estimation date is between (b)(6) 2023 and (b)(6) 2024 (iol implant and explant dates).Device evaluation: product evaluation was not performed because the product has not been received; it was reported the explanted iol was discarded.If product is received after initial closure, the pi and cp may be re-opened to complete the return investigation.Complaint history review: a search revealed that no other complaints have been received for this production order (po) number.Device history record (dhr) review: the manufacturing records for the product were reviewed, the units were released according to specification.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issues could not be confirmed as the device was not returned.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the dfw225 model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Complaints of blurred vision, photopsias, glare, and halos were noted post-operative day 1 onward.Best correct vision was reported as 20/25.There is no indication the patient symptoms being reported are debilitating.Through follow-up, additional information was received confirming the dfw225 iol was explanted in a secondary surgical procedure.The explanted iol was replaced with a diu225 21.0 diopter iol.There was no serious patient injury, no sutures, and no vitrectomy however the incision was enlarged - 3.0mm.Patient outcome post-lens exchange was reported as 20/40 uncorrected on post op-day 1.The suspect iol is not available for return as it was discarded.No further information is available.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19102361
• Report Number: 3012236936-2024-01066
• Device Sequence Number: 7428014
• Product Code: MFK
• UDI-Device Identifier: 05050474751873
• UDI-Public: (01)05050474751873(17)241003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White