MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Flashers (1864)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date explanted: not applicable as the iol remains implanted in patient's os.Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received (the lens remains implanted).If the product is returned regarding this evaluation the case will be reopened to complete sample evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nonconformance was found as part of the manufacturing record review.Historical data analysis: a search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number; voided file.No other complaints were received.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the dfw225 23.5 diopter intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Doctor reports patient has intractable positive photopsia.Over the last 5-6 months the doctor has tried everything to try to resolve her symptoms (including spectacle correction, photorefractive keratectomy (prk), and pilocarpine eyedrops); but ultimately concluded that an iol exchange is required.Through follow-up, additional information was received confirming prk was not performed and pilocarpine eyedrops were given (b)(6) 2022.Dfw225 iol explant is planned.No other interventions or patient injury reported.No further information is available.This report is for the patient's left eye.A separate report is being submitted for the patient's right eye.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15955960
• Report Number: 3012236936-2022-02942
• Device Sequence Number: 17735317
• Product Code: MFK
• UDI-Device Identifier: 05050474751927
• UDI-Public: (01)05050474751927(17)240909
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/09/2022

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: 09/09/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U235
• 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: 11/16/2022
• Initial Report FDA Received Date: 12/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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 Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White