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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intraocular lens (iol) had a bent/broken haptic.The lens was fully inserted in the patient's left eye and removed during the same procedure.Another johnson & johnson lens, model za9003 23.5 diopter was implanted as a replacement.The outcome did not significantly interfere with activities of daily life.No further information is available.
Additional Manufacturer Narrative
Patient weight/ethnicity: unknown/asked but unavailable.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.An attempt was made to obtain missing information; however, the account did not have further information.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 27, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received with a detached haptic and cut.The lens was cleaned and, a scratch on the optic body could be observed.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue ¿haptic damaged¿ was not confirmed.The other observed issue of "haptic detached" found during the product evaluation is related to the code of "haptic damaged¿ however, this could not be confirmed to be related to a manufacturing or design issue.The remaining observed issues found 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.Additional information provided with the product return and the date of event: 12/12/2022 was provided.No other information was provided.The following section has been updated accordingly: section b3: date of event: 12/12/2022.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: 16286953
• Report Number: 3012236936-2023-00232
• Device Sequence Number: 11982110
• Product Code: HQL
• UDI-Device Identifier: 05050474531789
• UDI-Public: (01)05050474531789(17)261005
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/24/2023

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: 10/05/2026
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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