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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight and ethnicity: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.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.An attempt has been made to obtain the missing information; however, the information was not available.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) had an amputated haptic.No further information available.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that device code was incorrectly chosen as 1069 - break in section h6: medical device problem code.Correct code should be 1261- material fragmentation.This field is updated to apply correct code.Section h6: medical device problem code: 1261.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 2, 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 both haptics were detached.The lens was cleaned, and lens damage as well as cosmetic issues were observed.The complaint issue could not be confirmed.However, the customer experience may be related to handling during insertion, and cannot be confirmed to be related to a manufacturing or design issue.Therefore, no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: upon further evaluation, the device evaluation results in the section h10 of 1st follow-up report of mfr-3012236936-2022-00209 had mentioned a statement that "complaint issue could not be confirmed".It should have actually indicated that "the complaint issue was confirmed".This report is being submitted to capture this error.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: 13362140
• Report Number: 3012236936-2022-00209
• Device Sequence Number: 3465787
• Product Code: HQL
• UDI-Device Identifier: 05050474528987
• UDI-Public: (01)05050474528987(17)260817
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2022

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: 08/17/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 03/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/25/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sex: Unknown