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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was not implanted.Section d6b: if explanted, give date: not applicable, as lens was not implanted, hence not explanted.Section h3-other (81): 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.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.
Event or Problem Description
It was reported that a preloaded intraocular lens (iol) was bent/broken haptic during handling prior to insertion.It was stated that there was no patient contact.No other adverse events.The procedure was completed using back-up iol of the same model and diopter size iol.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: jun 9, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation was performed under magnification.The complaint device presented with the lens inside the cartridge.The lead haptic was observed to be unfolded.The device assembly was inspected and no issues were identified.The lens was removed and presented with damage consistent with being folded in a cartridge.The complaint issue dc-haptic damaged was not confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.As per complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 16839715
• Report Number: 3012236936-2023-01074
• Device Sequence Number: 6861311
• Product Code: HQL
• UDI-Device Identifier: 05050474731585
• UDI-Public: (01)05050474731585(17)241001
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 10/01/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0115
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/09/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: Male