MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS 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	Blurred Vision (2137)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: unknown, information not provided.Phone number: (b)(6).Device evaluation: product testing could not be performed since the product was discarded.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed one complaint from this production order number, however the reported issue is unrelated this reported complaint and no product deficiency was identified in that case.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 model intra ocular lens(iol) was explanted from patient's left eye in a secondary surgical procedure due to patient's visual issues.Additional information was received stating that visual symptoms experienced by the patient was that bilateral optical images are too much.No medical/surgical interventions such as vitrectomy, incision enlargement or sutures were required.The replacement lens used is a non-johnson & johnson vision lens.The patient was doing well at the time of discharge.No further information provided.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11204224
• Report Number: 9614546-2021-07029
• Device Sequence Number: 19400604
• Product Code: POE
• UDI-Device Identifier: 05050474591745
• UDI-Public: (01)05050474591745(17)210721
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 07/21/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0150
• 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: 12/22/2020
• Initial Report FDA Received Date: 01/20/2021
• 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: 58 YR