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

Catalog Number	ZCB0000120
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgeon found a scratch mark on a non-preloaded monofocal intraocular lens (iol) during a procedure on (b)(6) 2025.The issue was identified after the lens was implanted, and there is uncertainty regarding whether the scratch was caused by the injector or if the lens itself was faulty.The lens was fully inserted.The customer indicated that the lens was inserted and removed during the same procedure and replaced with another monofocal iol, and the patient was fully recovered post-operation.Daily activities were not affected.Pre-operative vision was 6/24.There were no incidences of incision enlargement, no sutures, and no vitrectomy reported.There was no delay in the procedure.Upon follow-up, it was stated that medication was prescribed as part of the standard therapeutic regimen.No further information is available.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown, information not provided.Section d6b: if explanted, give date: unknown, information not provided.Section e1: title, email address, address, city, state, post office or zip code: unknown/not provided.Section e1: phone number: (b)(6).Section e2 and e3: unknown, information not provided.Section h3: other 81: product evaluation was not performed because the product has not been received.If product is received after initial closure, the product investigation (pi) maybe re-opened to complete the return investigation.The complaint issue reported could not be confirmed.Based on the 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.No nonconformity report, documentation or labeling changes, and further escalations are required.Johnson & johnson surgical vision will continue to monitor these types of complaints.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: 21752243
• Report Number: 3012236936-2025-000083
• Device Sequence Number: 15907973
• Product Code: HQL
• UDI-Device Identifier: 05050474531550
• UDI-Public: (01)05050474531550(17)271210
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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 Catalogue Number: ZCB0000120
• 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: 03/10/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown