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/date of birth, weight, ethnicity: unknown/not provided.Date of event: unknown, not provided.If implanted, give date: not applicable, no patient contact with product.If explanted, give date: not applicable, no patient contact with product.Telephone number: (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
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 lower body assembly had been detached at the hinge and that the cartridge was received separately from the handpiece, which is consistent with a handpiece that was disassembled.Furthermore, the plunger rod was observed to be in the advance and locked position.The no further issues were observed with the handpiece.Visual inspection of the lens revealed that it was received taped to the cartridge.The lens was cleaned and, lens damage was observed on the optic body.The complaint issue stuck in cartridge could not be confirmed.The complaint issue lens damage could be confirmed; however, it may be attributed to handling during disassembly by the customer, and cannot be confirmed to be related to a manufacturing issue.Furthermore, per the directions for use (dfu) product that is found to have an issue during inspection is not to be used and the product is not to be disassembled.Therefore, no product deficiency could be identified.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 other complaints were received for this po.Therefore, no escalations are required.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 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: 12686765
• Report Number: 2020664-2021-07878
• Device Sequence Number: 11758256
• Product Code: HQL
• UDI-Device Identifier: 05050474558083
• UDI-Public: (01)05050474558083(17)210418
• 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
• Report Date (Section B): 04/11/2022

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: 04/18/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000110
• 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: 03/24/2022
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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