MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's left eye in a secondary surgical procedure due to dysphotopsia.A non-johnson & johnson lens was used as a replacement.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between nov 11, 2021 and jan 25, 2022.The intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain additional information regarding the event; however, to date, no information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received from the account indicated that the patient¿s symptoms first noted on (b)(6) 2021.No additional surgical interventions required with the original surgery.The patient outcome was reported to be 20/40, patient was not satisfied.There was no patient injury.The patient ethnicity/race and weight was asked but reportedly that information is not available, so was not provided.The following fields were updated accordingly: section b3: date of event: (b)(6) 2021.Section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: feb 28, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half (w/ one half missing).No issues related to or could have contributed to visual issues were observed.Based on the return condition of the lens, no further product evaluation could be performed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 13664706
• Report Number: 3012236936-2022-00551
• Device Sequence Number: 17486706
• Product Code: POE
• UDI-Device Identifier: 05050474579057
• UDI-Public: (01)05050474579057(17)240128
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 01/28/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0180
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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