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

Model Number	ZCU150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d-6b date explanted: not applicable as the iol remains implanted, therefore not explanted.Section e-1 email address: unknown as information was not provided.Section e-1 establishment name: unknown as information was not provided.Section e-1 address: unknown as information was not provided.Section e-1 city: unknown as information was not provided.Section e-1 state, province, or territory: unknown as information was not provided.Section e-1 post office or zip code: unknown as information was not provided.Section e-1 telephone number: unknown as information was not provided.Section h3-81: the device was not returned for evaluation as it remains implanted in the patient¿s ocular dexter.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 - clinical code: 2140 glare-persistent and photophobia-persistent.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the zcu150 model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Patient stated for the past two years she has been having issues with her sight.Iol is causing her blindness in any kind of light and severe glare.On (b)(6) 2023, she saw her 5th doctor, and was informed that, the iol that was placed in her right eye, has rough edges.Patient reached out to request a refund, she was informed that any credits would be issued to the facility who purchased the iol.She indicated she will reach out to the surgeon who placed the iol.Patient was provided with complaint folder information, (b)(4), to provide to the surgeon.Through follow-up, additional information was received stating doctor has confirmed blindness in any kind of light.Doctor also has a photo of rough edges of the lens.Patient stated original iol implant doctor is no longer her doctor and provided original doctor contact information to obtain visual acuity measurements.Original iol implant doctor stated he has tried to call the patient multiple times to come in for an evaluation and she has not returned his calls.He recently sent her a letter requesting her to come in for an evaluation.If the patient responds, the doctor will be able to provide more information.No further information is available.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 16934328
• Report Number: 3012236936-2023-01242
• Device Sequence Number: 15316256
• Product Code: HQL
• UDI-Device Identifier: 05050474657809
• UDI-Public: (01)05050474657809(17)250227
• 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: 2021
• 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): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U205
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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: Other
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White