MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown, information not provided.Race/ethnicity: unknown, information not provided.Phone number: (b)(6).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 reported that there was lens exchange of a zcu toric intraocular lens (iol) due to refractive surprise and residual cylinder.The procedure was completed successfully using a model zcu300 18.5 diopter lens.Additional information states there was post-op refractive error despite reliable pre-op biometry and intraoperative asymmetry, and blurred uncorrected visual acuity (ucva) because of residual refractive error.There was no delay in procedure.Visual acuity pre-op: 20/80, visual acuity post-op: 20/40.No further information provided.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11174933
• Report Number: 9614546-2021-07013
• Device Sequence Number: 19385755
• Product Code: HQL
• UDI-Device Identifier: 05050474657755
• UDI-Public: (01)05050474657755(17)250203
• 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: 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
• Report Date (Section B): 01/14/2021

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: 02/03/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U180
• 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: 12/16/2020
• Initial Report FDA Received Date: 01/14/2021
• 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