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	Foreign Body Sensation in Eye (1869); Visual Disturbances (2140)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown as information was not provided.Date explanted: not applicable as the iol remains implanted in the patient's ocular sinister (left eye).Manufacturer telephone number: (b)(4).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s os therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye), and as soon as the patient opened her eyes she saw a sort of shadow on the iol.She has seen five (05) different ophthalmologists and they have all said the surgery was perfect.Her vision is quite good, 20-20, but, she is miserable due to negative dysphotopsia.Her eye feels heavy and as if there¿s something in it all the time; sunglasses help.Patient was told that there are a small percentage of people who get this bad side effect.Patient's vision has always been excellent and she never wore glasses, except for reading.Through follow-up additional information was received clarifying her vision is good, it¿s the sensations/symptoms in her eye that are debilitating.As soon as she opened her eyes after surgery she noted there was sticking in her eye and there was a shadow.All five (05) doctors confirmed negative dysphotopsia diagnosis and stated this might go away in time.Patient was given drops for dry eye to lessen the problem and was told to wear glasses.Wearing glasses does help and she filled a prescription for no correction glasses.They do help somewhat but after an hour or she gets a headache.No further information is available.

• 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: 12112591
• Report Number: 9614546-2021-07249
• Device Sequence Number: 4601236
• Product Code: POE
• UDI-Device Identifier: 05050474579125
• UDI-Public: (01)05050474579125(17)230517
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 05/17/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0215
• 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: 06/06/2021
• Initial Report FDA Received Date: 07/02/2021
• 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