MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Disturbances (2140)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown, not provided, but the best estimate date is since (b)(6) 2018 as reportedly the issues were noted after the cataract surgeries.If explanted, give date: not applicable as the device remains implanted.Telephone number: (b)(6).(other): the intraocular lens (iol) is not returning for evaluation as the lens 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A patient reported that after his bilateral surgeries in 2018, his eyes would close on him continuously and it is a struggle to keep them open while driving.The patient is light sensitive and indicated that his eyes keep closing even when he is in a shaded environment, not exposed to lights.The patient almost quit driving because of his symptoms.After his surgery, the patient informed his doctor of the symptoms, but the doctor did not respond to his complaint at the time and told him to come back after one year.The patient needed to retire as he is (b)(6) and still feels like he has energy to keep going, but this problem is hurting him.The patient has ordered uv protection sunglasses which uses them.The patient made an appointment to see a specialist on (b)(6) 2021, this would be his second appointment.The first time, the patient was told that he has dry eye and was prescribed with thera tears (1drop/4times a day) which he sometimes uses it even more that 4 times/day.The patient indicated that he did not have any dry eye issues before his cataract surgeries.The patient noted that the drops did not help with his symptoms.The doctor stated that the patient¿s eyes are lazy which botox can help him with that issue.The patient was referred to another doctor for botox treatment which he is going to make that appointment soon.Ever since the surgeries the patient has been feeling worse every day.The patient indicated that he has adapted himself to perform his daily activities and although he has to constantly force his eye open even if with his fingers he still performs his daily activities and drives as well although not as much long distance as he used to, due to the problems he is having now with his eyes.No further information was provided.This emdr report is for patient's right eye.A separate report will be submitted for the left eye of the patient.
Additional Manufacturer Narrative
Additional information: additional information received from the patient indicated that he can only open his eyes without issue when in darkness.The patient reported having walked into walls.The patient has seen 5 doctors, and all say that he does not have issues.However, the patient feels otherwise.In addition to the dry eye that patient reported before, he has these conditions: stage 2 renal disease.The patient uses diet to keep his renal function close to normal and has not ever been on dialysis.The patient does take potassium supplements.Pre-skin cancer.Preventative treatment is with creams.A condition where the breathing passages in his nose close off.The patient had surgery in (b)(6) 2021 to fix this issue.The patient also may be suffering from allergies.In addition, the patient uses 100%uvlight and 100% blue light glasses.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 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 11305829
• Report Number: 9614546-2021-07057
• Device Sequence Number: 16987791
• Product Code: POE
• UDI-Device Identifier: 05050474605305
• UDI-Public: (01)05050474605305(17)211214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 12/14/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U250
• 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: 01/12/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male