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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(4).The device was not returned for evaluation as the lens remain implanted in the eye.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
It was reported that when the intraocular lens (iol) unfolded a crack was found on the nasal side of the iol.Surgeon decided to leave the lens in situ.The patient has age-related macular degeneration (amd) and has poor peripheral vision.Per the surgeon this anomaly would not affect the patient's overall vision.Through follow up we learned that there was no feedback on the patient's condition and that the preloaded device was discarded.No further information was provided.
Additional Manufacturer Narrative
Section h3: device evaluated by manufacturer? yes.Device evaluation: product evaluation was performed on the customer provided photograph and video.A picture and a 12 second video provided in the complaint shows the final implantation step of an alleged pcb00 (tecnis itec preloaded 1-piece monofocal intraocular lens).Lens breakage like marks located in the mid periphery/periphery region of the lens optical portion can be observed in the picture and video.The root cause of the issue and its potential clinical impact cannot be determined from a photograph and video assessment.The complaint issue of lens damaged 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.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16449381
• Report Number: 3012236936-2023-00277
• Device Sequence Number: 5416789
• Product Code: HQL
• UDI-Device Identifier: 05050474558328
• UDI-Public: (01)05050474558328(17)250912
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 09/12/2025
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000230
• Was Device Available for Evaluation?: No
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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