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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a posterior capsule rupture with vitreous prolapse when patient coughed.No further information is provided.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown/ not provided.Section d6b: if explanted, give date: not applicable, as lens was not explanted section e1: reporter: first/given name: unknown/ not provided section e1: reporter: middle name: unknown/ not provided section e1: reporter: last name: unknown/ not provided section e1: reporter: email address: unknown/ not provided section e1: reporter: address: address - line 2: unknown/ not provided section e1: reporter: address: city: unknown/ not provided section e1: reporter: address: state, province, or territory: unknown/ not provided (b)(6) device evaluation: at the time of the investigation, device was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results 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: 19996170
• Report Number: 3012236936-2024-000222
• Device Sequence Number: 20940602
• Product Code: HQL
• UDI-Device Identifier: 05050474531802
• UDI-Public: (01)05050474531802(17)270429
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000245
• 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: 07/22/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown