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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation as it remains implanted; 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 the intraocular lens was explanted due to patient being unhappy with vision, distance visual acuity (va) is not sharp and near va is not clear.Patient also stated vision is not clear with blurry and some irritation.There was no delay and no incision enlargement, no sutures, no vitrectomy at explant.The explanted lens was replaced with model zmb00 15.5 diopter iol.The explanted lens was discarded.Visual acuity pre-operative: 20/25.Visual acuity post-operative: 20/20-3 (post-op day one).No further information provided.
Additional Manufacturer Narrative
Correction mdr: the customer state the jnj representative was reached on 12/9/2020 dropping a voicemail requiring a correction to initial mdr that stated 12/10/2020 as the aware date.Manufacturer name city and state: address country: corrected to united states of america.Initial mdr indicates that the lens remains implanted which is incorrect as the lens was explanted and it was discarded respectively.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco, puerto rico
• MDR Report Key: 11143953
• Report Number: 2648035-2021-07010
• Device Sequence Number: 10920601
• Product Code: MFK
• UDI-Device Identifier: 05050474560604
• UDI-Public: (01)05050474560604(17)230909
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 09/09/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 03/13/2021
• 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