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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information section d-6b date explanted: not applicable as the iol remains implanted in the patient¿s ocular sinister (left eye), therefore not explanted.Section h3-81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the dfw150 intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Patient reports from the moment she awoke from surgery she could tell her vision was not right.When she left she had a hard time judging the depth of the curb she stepped off of.She cannot see close up with that eye, her distance is blurry and about 20/40, and she has no depth perception.She is unable to drive, has trouble with stairs and curbs, and even has trouble with viewing her computer.She is a real estate agent by trade and usually drives a lot.In addition, she has constant eye strain all the time, that gives her a headache.Her doctor and the second opinion she received both stated the placement looked fine, she had no swelling, and the surgery was good.Through follow-up, additional information was received from the patient stating depth perception is a huge issue.It has gotten better but it's not great; things are not lining up.Patient confirmed driving was affected and she could not drive for a while but due to the nature of her business, real estate agent, she had to find a way to drive.She covers her left eye with an eye patch and uses right her right eye to drive during the day but does not drive at night.She does not allow passengers in her car when she is driving during the daytime.She also cannot read or see her computer.Patient obtained a second opinion regarding her vision, doctor stated cornea is fine and pupil is fine however the doctor was not familiar with the dfw150 iol.Iol is not available for return as it remains implanted.No further information is available.
Additional Manufacturer Narrative
In review of the file, it was noted that date of report submission was not provided when 3012236936-2023-01154 follow-up report 1 was submitted on 29-sep-2023.The following has been updated accordingly: section b-4 date of report: 29-sep-2023.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received confirming dfw150 iol was explanted in a secondary surgical procedure on (b)(6) 2023 and replaced with a non-johnson & johnson 7.5 diopter iol.There was no patient injury however iol aberrations for exchange diagnosis was reported.Patient outcome post-lens exchange is unknown.The explanted iol is not available for return.No further information is available.The following fields were updated based on the updated information received: section d-6b date explanted: 31-aug-2023.Section h3-81: the device was not returned for evaluation.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.Section h-6 health effect - impact code: 4629.The code provided in the initial report 2199 - no health consequences or impact is no longer applicable.Section h-6 type of investigation 4114.The code provided in the initial report 4117 - device not accessible for testing is no longer applicable.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16899401
• Report Number: 3012236936-2023-01154
• Device Sequence Number: 20537968
• Product Code: MFK
• UDI-Device Identifier: 05050474750982
• UDI-Public: (01)05050474750982(17)240224
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2023

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: 02/24/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U060
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 09/29/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 09/29/2023; 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2021
• 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; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White