MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; TECNIS SYMFONY OPTIBLUE

Model Number	ZXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is (b)(6) 2021.Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to "mechanical failure".There was no incision enlargement, no vitrectomy and no sutures required.No patient post-op injury.It was learned that by mechanical failure they meant that the patient complained of decreased depth perception, worse when driving.He felt like his vision was actually better prior to the surgery.Distance vision appeared cloudy.Near vision was terrible after surgery and he stated he could not see anything up close.No other information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; returned to manufacturer on: 3/16/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.And that the lens was received cut in half (but not separated).Which is consistent with a lens that was handled during explant.Furthermore, fibers were observed on the lens, which can be attributed to receiving the lens wrapped in gauze and cannot be confirmed, to be related to manufacturing.Based on the return condition of the lens, no further product evaluation can be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated.And revealed, that the product was manufactured and released according to specifications.A search revealed, that no other complaints were received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: TECNIS SYMFONY OPTIBLUE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11449631
• Report Number: 9614546-2021-07078
• Device Sequence Number: 4049017
• Product Code: POE
• UDI-Device Identifier: 05050474734043
• UDI-Public: (01)05050474734043(17)250928
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 09/28/2025
• Device Model Number: ZXR00V
• Device Catalogue Number: ZXR00VU160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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