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 Code	Halo (2227)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's operative eye due to a mechanical complication-halos.The visual acuity (va) pre-operative: 20/50 and va post-operative: 20/20.The incision was enlarged and sutures and a vitrectomy were required.The patient is doing well post-operatively.No other information was provided.
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2022-(b)(6) 2022.The device 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.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: further information was provided and reported dr.(b)(6) was the explanting surgeon.It was initially reported as surgeon bing chiu.Additional info: through follow-up, the date of event was provided and the affected eye was the left eye.Another johnson & johnson lens, model zcb00 19.0 diopter was implanted as a replacement.The customer confirmed the product was returned to j&j for product evaluation.The following sections have been updated accordingly: section b3: date of event: (b)(6) 2022.Section e1: first/given name: (b)(6).Section e1: last name: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: jan 4, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the suspect lens was received an a bag with a foam swab.Visual inspection under magnification revealed that the lens was received cut in half.The lens was cleaned and inspected and lens damage and scratches were observed on the optics of the lens.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: 15886770
• Report Number: 3012236936-2022-02943
• Device Sequence Number: 17424020
• Product Code: MFK
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240912
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/06/2023

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: 09/12/2024
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 01/23/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/27/2022; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2021
• 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