MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	04/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight, ethnicity: information unknown/not provided.If explanted; give date: n/a (not applicable).The lens remains implanted.The intraocular lens (iol) is not returning 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient is experiencing significant vision problems and poor vision with intraocular lens (iol).The patient reported she had multiple surgeries afterwards to try and correct the problems, but to no avail.No additional information was provided to johnson & johnson surgical vision.Through follow-up, it was learned that the patient's night distance is bad, on-coming headlights are out of focus, and patient complained of dry eyes which she did not have prior to surgery.The patient has been using over-the-counter (otc) eye drops to relieve the dry eyes.The patient had a yttrium aluminum garnet (yag) performed in both eyes (ou) sometime in 2016 after her implants, however, it did not help with her visual issues.Lasik was performed in the left eye only which also did not help with her visual issues.The patient also tried hard contact lenses (cl) which were no help.The lenses remain implanted at this time.No additional information was provided to johnson & johnson surgical vision.Patient had bilateral lens implants.This report captures the lens implanted in patients right eye.A separate report will be filed for the left eye.
Additional Manufacturer Narrative
Additional info: further information was provided and the patient also complained when she has sunglasses on, she can see small concentric circles in her field of vision.It only happens when she is wearing sunglasses.No other information was provided.The following section has been updated accordingly: section h6: health effect - clinical code: 2140- visual disturbance all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12801460
• Report Number: 2020664-2021-08095
• Device Sequence Number: 17529891
• Product Code: MFK
• UDI-Device Identifier: 05050474560680
• UDI-Public: (01)05050474560680(17)191217
• 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: 2016
• 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): 12/13/2021

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: 12/17/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0205
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 11/20/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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 Sex: Female