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	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not applicable, as there was no patient contact.If implanted, give date: not applicable, as there was no patient contact.If explanted, give date: not applicable, as there was no patient contact.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaints for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was defective and could not be implanted.There was no patient contact.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: apr 26, 2023 section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge and overridden by the plunger rod.The lead haptic was also unfolded, in a way consistent with an overridden lens.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint or observed issues were identified.The lens was removed from the cartridge and cleaned, revealing no issues.The complaint issue was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.There is no indication of a 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: 16748082
• Report Number: 3012236936-2023-00921
• Device Sequence Number: 14271989
• Product Code: HQL
• UDI-Device Identifier: 05050474635968
• UDI-Public: (01)05050474635968(17)240630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 06/30/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000140
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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