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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: information unknown/not provided.Date of event: exact date was not provided.Best estimate is (b)(6) 2021.Only information provided was symptoms were likely observed during the recovery phase.Device evaluated by mfr: the intraocular lens (iol) is not returning for evaluation as it is 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 initially reported that the patient a patient was not happy with their outcome post-implant of a toric intraocular lens (iol) in the right eye.The lens was subsequently explanted, no vitrectomy was required.The patient was reported to be fully recovered.Through follow-up, it was learned that the patient was unhappy due to poor quality of vision with the multifocal iol.The patient complained of seeing rings everywhere during the day and at night.The explanted lens was replaced with another johnson & johnson lens (model za9003 and lower diopter 23.5).The explanted lens was discarded.No additional information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11904418
• Report Number: 2648035-2021-07868
• Device Sequence Number: 19754851
• Product Code: POE
• UDI-Device Identifier: 05050474579194
• UDI-Public: (01)05050474579194(17)230828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 08/28/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/28/2021
• 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