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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol) was inserted and then removed because the lens would not center due to tear in the capsule.The doctor tried to implant the iol in the sulcus to begin with and explanted it after the lens failed to center properly.There was not enough zonular or sulcus support to keep the lens centered.The doctor confirmed that it was an eye anatomy pre-existing issue which was discovered after the lens was inserted in the eye.There doctor confirmed that there was no issue with or allegation against the johnson & johnson product.The patient was left aphakic and was referred to a different doctor.The device was discarded.No further information is available.
Additional Manufacturer Narrative
Weight and ethnicity: unknown, no further information is available.Implant date: if implanted, give date: not applicable, as lens was inserted and removed during the same procedure.Explant date: if explanted, give date: not applicable, as lens was inserted and removed during the same procedure.The device was not returned for evaluation as it was discarded; 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 14502127
• Report Number: 3012236936-2022-01336
• Device Sequence Number: 5202655
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)260812
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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 Expiration Date: 08/12/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• 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: 04/30/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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: Required Intervention
• Patient Sex: Male