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

Model Number	ZLU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided.Best estimate of date of event is between on (b)(6) 2022 and on (b)(6) 2023.Section h3-other (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.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor performed two (2) cataract surgeries, one on each of the patient's eyes.It was stated that the patient never had problems with halos at night, and did not even know the meaning of a halo.However, after the surgeries, the patient had multiple halos of all colors of the street lights in her line of sight when driving at night.There were so many, that it left the patient in an extremely dangerous situation if she were to drive at night.Thus, the patient did not drive at night since on (b)(6) 2022.The patient was informed that sometimes halos and glares resolve themselves with time; but patient claimed that hers did not.It was learned that explant occurred later but no other information was provided.This report captures event for suspect lens in right eye (od).Event for left eye (os) is determined to be not reportable at this time.
Additional Manufacturer Narrative
Additional information: further information received that the replacement lens for the right eye (od) explant was a non-johnson and johnson lens.Also, as to patient outcome on od, patient well post-op, no injury.Apparently visual issues on left eye (os) are only some halos, not affecting regular activities, no plan to remove lens os.Patient race is white, weight around 170 lbs.Fields below updated.Section a4: weight: 170 lbs.Section a5: race: white.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: upon further review it was noted that information that dr.Nicole fram explanted the suspect lens was inadvertently missed in the 1st supplemental report submitted.Therefore, this 2nd supplemental report is being submitted.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: 17191256
• Report Number: 3012236936-2023-01574
• Device Sequence Number: 17594162
• Product Code: MFK
• UDI-Device Identifier: 05050474689381
• UDI-Public: (01)05050474689381(17)250528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 07/26/2023

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: 05/28/2025
• Device Model Number: ZLU150
• Device Catalogue Number: ZLU150U210
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 07/26/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/10/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White