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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: information unknown/not provided.Asku.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that the jnj intraocular lens was explanted from the patient¿s left eye due to them experiencing halos and blurry vision.Their pre-operative visual acuity was 20/60 and post-operative 20/30.The incision had to be enlarged.There were no sutures used, no vitrectomy required and no delay in procedure.Reportedly, the patient is doing well after the explant.No further information was provided.
Additional Manufacturer Narrative
This follow-up report is to correct the initial submission.In the initial report the following fields were completed based on the wrong serial number provided by the customer.They've now clarified the correct serial number is (b)(6).The following fields are now updated accordingly.Section d4 additional device information model number: dfr00v, catalog number: dfr00vu190, serial number: (b)(6), expiration date: sep 27, 2024, unique identifier (udi) number: (b)(4), device manufacture date: sep 27, 2021.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 12, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the suspect iol was received cut with viscoelastic residue on the surface.The lens was cleaned and visual inspection found scratches on the lens surface.No other issues were identified.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be 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: 15974338
• Report Number: 3012236936-2022-02946
• Device Sequence Number: 5453852
• Product Code: MFK
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240927
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023
• 2 Devices were Involved in the Event: 1 2

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: 09/27/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU190
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 01/27/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/18/2023; 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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: Male