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	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021.Device evaluated by mfr: the device was not returned for analysis as the lens is not available for return.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.Other text : lens not available for return.
Event or Problem Description
It was reported that a zlb00 model intraocular lens(iol) was explanted from patient's right eye due to refractive error.Incision was enlarged to explant lens from patient's eye but no vitrectomy was done.This event was observed during post operative examination.There was also no delay in treatment.It was stated that suspect product is not available for return.No further information available.
Additional Manufacturer Narrative
Corrected data/additional data: additional details received states that there was no issue suspected with the lens and the patient was doing good at the time of discharge.Also, h6: health effect: impact code: was inadvertently coded in the initial mdr submitted as 4625.When it should not have been coded anyway.Moreover, surgeon details were provided.As a result the following fields have been updated: section e1: corrected data: first/ given name: richard j.Section e1: corrected data: last name: mukool.Section e2: corrected data: health professional: yes.Section e3: corrected data: occupation: physician.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 PR 00610
• MDR Report Key: 12129709
• Report Number: 2648035-2021-08096
• Device Sequence Number: 11660680
• Product Code: MFK
• UDI-Device Identifier: 05050474560659
• UDI-Public: (01)05050474560659(17)230911
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 08/03/2021

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: 09/11/2023
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: 63 YR