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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a, if implanted, give date: not applicable.There's no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Hence, not explanted.Section h3-other (81): the device has not been 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.Attempts have been made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson(jnj) intraocular lens (iol) has a bad haptic.The issue was noticed upon opening the package.There was no patient contact.Customer clarified that the inner pouch was not opened or unsealed when it was received.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 30, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint handpiece with the iol was received.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge tip.Inspection of the cartridge revealed that there was no viscoelastic residue dispersed throughout the cartridge, suggesting that an inadequate amount of ovd may have contributed to the observed issue.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.The lens was removed from the cartridge, however it came out in pieces.The lens could be observed to be torn, and damaged, as well as having detached haptics.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 17099113
• Report Number: 3012236936-2023-01445
• Device Sequence Number: 16618084
• Product Code: HQL
• UDI-Device Identifier: 05050474635920
• UDI-Public: (01)05050474635920(17)231017
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 10/17/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000120
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2020
• 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