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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.The device is not received; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response 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 cut out from the patient's right eye as the lens was not manufactured correctly.The haptic of the lens broke off while pulling it out.The patient had some corneal edema.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: dec 20, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed trace amounts of viscoelastic residue inside of the cartridge.Further observation revealed a lens was stuck inside of the cartridge and that the lens was overridden by the plunger rod.The handpiece was disassembled and the assembly was inspected, presenting with no assembly issues.The lens was removed and cleaned, presenting with lens damage and cosmetic issues.The complaint issue haptic detached could not be confirmed.The complaint issue lens damage could be confirmed; however, this may be attributed to excessive force and an inadequate amount of ophthalmic viscoelastic device (ovd), suggested by the fact that the lens was overridden by the plunger rod and the lack of viscoelastic residue found inside of the cartridge, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional investigation request (ir) for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 12928004
• Report Number: 3012236936-2021-00101
• Device Sequence Number: 5737464
• Product Code: HQL
• UDI-Device Identifier: 05050474558267
• UDI-Public: (01)05050474558267(17)231124
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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: Unknown