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

Model Number	DCB00
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pre-loaded dcb00 model intraocular lens (iol) trailing haptic was wedged between the cartridge and paddle, and was unable to release.Ultimately, the haptic broke off and the iol had to be explanted.There was patient contact however, extent of contact is unknown.The same procedure was completed successfully using j&j backup lens with the same model and diopter size.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age and date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted, therefore not explanted.Section h3-81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 01-jun-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint handpiece was received inside of a bag.The complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the complaint handpiece was received with a small piece of a haptic stuck and overridden by the plunger rod in the cartridge tip.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint or observed issues could be identified.Visual inspection under magnification revealed that the complaint lens was received cut and with small portion of the haptic detached.The lens haptics were measured, all measurements came back within specification.Complaint issue of dc-haptic detached and dc-stuck in cartridge were identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other issues observed 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.Relationship between the device and the reported incident could not be determined.Therefore, there is no indication of a product deficiency or product malfunction.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: 16943372
• Report Number: 3012236936-2023-01252
• Device Sequence Number: 3340097
• Product Code: HQL
• UDI-Device Identifier: 05050474636323
• UDI-Public: (01)05050474636323(17)240521
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/06/2023

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: 05/21/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000320
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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