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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during insertion the intraocular lens (iol) haptic broke and jammed in the pscst30 cartridge; account stated possible use error and folding issue.Another lens with the same model and diopter was implanted in the patient¿s ocular dexter (right eye).There was no medical and no surgical intervention.No further information is available.
Additional Manufacturer Narrative
Patient weight, ethnicity and race: unknown as information was asked but not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted; therefore, not explanted.Concomitant medical products: pscst30 cartridge lot unknown, ovd, balanced salt solution (bss) & si40.Device evaluated by mfr: the device was not returned for analysis therefore, a visual 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 were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 25-mar-2022 section h-3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the lens was received with a lens detached.The lens was cleaned, and lens damage and scratches could be observed on the lens.No further issues could be identified with the lens.The complaint issues (haptic damaged and stuck in cartridge) were not confirmed.However, the observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issues were not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code "medical device problem code: 42983 - mechanical jam" was in advertently not entered in the section "h6" of the initial report.Therefore, the correction has been included in this supplemental mdr report as indicated below: section h6: medical device problem code: 42983.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 13447676
• Report Number: 3012236936-2022-00288
• Device Sequence Number: 14793153
• Product Code: HQL
• UDI-Device Identifier: 05050474530706
• UDI-Public: (01)05050474530706(17)240920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 09/20/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200205
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 05/18/2022; 10/19/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/25/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2019
• 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
• Patient Sex: Female