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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2020.The device was not returned for analysis 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcu150 model intraocular lens (iol) was explanted from patient's left eye as patient had dysphotopsia.There was no sutures and vitrectomy but customer does not know if there was incision enlargement.Patient is fully recovered and doing fine.Additional details received from follow up states that there was no issue suspected with the lens and no prescription was given to the patient outside of the normal post-operative treatment.The replacement lens used is a same model but different diopter lens.Suspect product was not saved.No further information available.
Additional Manufacturer Narrative
Additional details were received stating that patient¿s condition significantly interfered with daily activities of life like watching tv and also additionally surgeon and patient details were received.As a result, the following fields have been updated.Section a4: patient weight: 162.6 lbs section e1: first/ given name: corrected data: (b)(6).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
• MDR Report Key: 11398180
• Report Number: 2648035-2021-07327
• Device Sequence Number: 14298246
• Product Code: HQL
• UDI-Device Identifier: 05050474657854
• UDI-Public: (01)05050474657854(17)240903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 09/03/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 73