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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, ethnicity: unknown/ not provided.Date of event: unknown, not provided.Implant date: if implanted, give date: not applicable, no patient contact with product.Explant date: if explanted, give date: not applicable, no patient contact with product.(b)(6).The intraocular lens (iol) 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.
Event or Problem Description
Customer reported lens damaged and stuck in cartridge with a model pcb00 tecnis itec preloaded device.There was no patient involvement.No additional information provided.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes returned to manufacturer on feb 18, 2022 section h3.Device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the preloaded device was returned damaged around the lower body assembly.The complaint lens was also observed stuck in the cartridge of the device and overridden by the plunger rod which was also observed to be bent.Dried viscoelastic residue was also observed expelled from the cartridge tip.The handpiece was reassembled to confirm that there was no issues with the assembled parts.Therefore, the observed gap may be attributed to an excessive force applied to the lens during advancement.The complaint issue "dc-stuck in cartridge" was confirmed (dc-lens damage was not confirmed); however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.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.
Additional Manufacturer Narrative
Corrected data: as part of an internal review of our mdrs it was identified that the code 2983 for stuck in cartridge was not provided on the initial report submitted therefore, needs to be corrected.The additional medical device problem code is 2983.Field below is updated: section h6: medical device problem code: 2983.All pertinent information available to johnson and 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12686763
• Report Number: 2020664-2021-07873
• Device Sequence Number: 3983982
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)200601
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

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: Other
• Device Expiration Date: 06/01/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 04/28/2022; 10/13/2022
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 05/10/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2017
• 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