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

Catalog Number	ZCB0000225
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown; information not provided.Section e1: title, email address, address, post code/zip code: unknown, information not provided.Section e1: telephone number: (b)(6).Section h3: product evaluation was not performed because the product has not been received.If product is received after initial closure, the product investigation and complaint (if necessary) may be 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.
Event or Problem Description
It was reported that after implanting a non-preloaded monofocal intraocular lens (iol), the lens tilted, and a posterior capsule rent was noted.The issue was first identified after the lens was fully inserted.This lens was removed during the same procedure and an anterior chamber intraocular lens (aciol) was implanted.There was incision enlargement, sutures and vitrectomy required.The vision preoperative was 3/60.The patient's postoperative vision was unknown.The patient status was temporarily impaired.There was no delay in the procedure.The end-user did not seek any medical attention.Medication was prescribed.Directions for use were followed.No further information is available.

• 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: 21268631
• Report Number: 3012236936-2025-000024
• Device Sequence Number: 15579683
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)271216
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZCB0000225
• 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: 01/06/2025
• Initial Report FDA Received Date: 01/29/2025
• Date Device Manufactured: 12/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown