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

Model Number	Z9002
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate on last yag procedure on (b)(6) 2021.If implanted; give date: unknown, not provided, best estimate is prior to first yag procedure on (b)(6) 2017.If explanted; give date: not applicable as lens remains implanted.Other : the intraocular lens (iol) is not returning for evaluation as it is still implanted, therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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 bilateral z9002 intraocular lens (iol) were implanted in the patient's eye and developed reticular posterior capsular opacification (pco).Yttrium-aluminum garnet (yag) laser treatment was performed and was indicated that the deposits did not come off.Through additional information it was indicated that 7 years after bilateral implantation, patient developed reticular iol deposits.There were several yag procedures from 2015 to recent as (b)(6) 2021.There has not been any injuries, just decreased best corrected acuity.The pco has decreased activities of daily living.This mdr report is to capture the right eye (od).A separate report will be submitted for the left eye (os).

• 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
• MDR Report Key: 11283115
• Report Number: 2648035-2021-07203
• Device Sequence Number: 3440541
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713(17)141120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 11/20/2014
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention