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

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ asked but not available.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device was not returned for analysis.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was fully inserted into patient's right eye, however, was removed during the same procedure as the lens was scratched.Another lens of same model and diopter was used as the replacement.The patient has recovered.No other information was available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: returned to manufacturer on: jun 22, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint lens was received cut in half (one half missing).The lens was cleaned and, a cosmetic issue separate from the cut could be identified.Based on the return condition of the lens, no further product evaluation could be performed.The reported complaint issue was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 14599068
• Report Number: 3012236936-2022-01447
• Device Sequence Number: 6085601
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)250910
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2025
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000205
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT CJ32734
• Patient Age: 73 YR
• Patient Sex: Female