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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Flashers (1864)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received.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 dfw150 23.0 diopter intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Doctor reports patient has intractable positive photopsia.Over the last 5-6 months the doctor has tried everything to try to resolve the patient's symptoms (including spectacle correction, prk, and pilocarpine eyedrops); but ultimately concluded that an iol exchange is required for a toric monofocal lens; zcu150 240.Diopter.Through follow-up, additional information was received confirming photorefractive keratectomy (prk) was performed on (b)(6) 2022 and pilocarpine eyedrops were given (b)(6) 2022.Additional information was received confirming dfw150 iol explant was performed (b)(6) 2022 and replaced with a zcu150 24.0 diopter iol.There was no complications, such as capsular tear, no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.Patient outcome post-lens exchange was reported as: stable.No further information is available.This report is for the patient's right eye.A separate report is being submitted for the patient's left eye.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 12-jan-2023.Device evaluation: the suspect iol was cleaned, and visual inspection was performed, and lens damage was observed on the surface.No other issues were identified.Complaint issues were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 15955956
• Report Number: 3012236936-2022-02941
• Device Sequence Number: 7335042
• Product Code: MFK
• UDI-Device Identifier: 05050474751323
• UDI-Public: (01)05050474751323(17)241205
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 12/05/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/10/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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