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

Model Number	PCB00
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to implant the preloaded intraocular lens (iol) in the right eye, the device got stuck and would not come out of the cartridge.The plunger "reaches the top of its travel" and did not eject the lens, which got stuck inside the cartridge.The surgeon opened the disposable injector and managed to remove the lens from the cartridge.Upon review of the lens under the microscope, the surgeon realized that one of the haptics was damaged, remaining separated from the optical body of the lens, therefore the lens was unable to be used and the surgeon implanted a non-johnson and johnson iol in the right eye.No patient injury was reported.No further information was provided.
Additional Manufacturer Narrative
Section a2 and a4: unknown; requested but not provided.Section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted, therefore not explanted.Section e1: telephone number: (b)(6).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.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint handpiece was received with the lower body broken and the cartridge removed from the handpiece, suggesting that the customer damaged it while removing the lens from the cartridge.Based on the return condition of the handpiece, no further product evaluation could be performed.The lens was cleaned and, one haptic was observed to be detached.The remaining haptic was measured and passed dimensional inspection.The complaint issue stuck in cartridge was not confirmed.The complaint issue of haptic detached was 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 issue observed during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this production order number has been received.Conclusion: as per complaint investigation results, the product was released within specifications.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 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: 17159449
• Report Number: 3012236936-2023-01539
• Device Sequence Number: 7201207
• Product Code: HQL
• UDI-Device Identifier: 05050474558151
• UDI-Public: (01)05050474558151(17)231201
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 12/01/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: Male
• Patient Ethnicity: Hispanic
• Patient Race: White