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 Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted, the patient was seen in (b)(6) 2022 and was very unhappy with the vision in the left eye.The patient complained of poor vision (20/25), but mostly debilitating glare.The patient continued to go back to the surgeon over a year's time, being continually assured that things would get better.The patient does not want to return to the surgeon for any care and does not want to have the right eye done until this is resolved.The surgeon is considering recommending replacement of the iol with a standard monofocal iol.Pre-operative, the patient was a high minus - 10.00 with best corrected visual acuity 20/50.Through follow-up, it was learned that the patient's symptoms first started on (b)(6) 2021.There has been no medical or surgical intervention required and no planned interventions.The lens remains implanted.The patient will be having a lipiflow treatment done on (b)(6) 2023.No further information was provided.
Additional Manufacturer Narrative
Ethnicity: unknown; requested but not provided.If explanted, give date: not applicable, as the lens remains implanted.The device was not returned for evaluation as it remains implanted; 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.Multiple attempts have been made to obtain the missing information, however, to date, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: through follow-up, it was learned that the patient does not complain of dry eye or irritation in left eye (os), but does complain of post-operative ¿glare¿.In thinking the glare may be meibomian gland dysfunction (mgd) related and lipiflow treatment is being tried to try and reduce symptoms before explant alternative.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16486776
• Report Number: 3012236936-2023-00563
• Device Sequence Number: 15183260
• Product Code: POE
• UDI-Device Identifier: 05050474591691
• UDI-Public: (01)05050474591691(17)220720
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 07/20/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White