MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown, information not provided.Section b3: date of event: unknown, not provided.Best estimate of date of event is between mar.4, 2024 and apr 29, 2024.Section h3- no: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that non preloaded toric ii intraocular lens (iol) was explanted from the patient's right eye (od).It was noted that there was no product issue.However, it was learnt that the lens was replaced with non johnson and johnson light adjustable lenses per patient's request.The patient is doing well.There was no patient injury.Patient is not experiencing any issues at this time.No other information is available.
Additional Manufacturer Narrative
Corrected data: in review it was noted that in the initial report submitted, patient age and date of birth, gender, cisgender, implant and explant dates, were provided incorrectly.Therefore, it has been corrected in this supplemental report.The following fields are updated accordingly.Section a2: age and date of birth: 60 yrs.Old and (b)(6) 1964.Section a3: gender: female.Section a3: sex: cisgender: woman/girl.Section d6a: if implanted, give date: (b)(6) 2023.Section d6b: if explanted, give date: (b)(6) 2024.Additional information: new information received that there was no other adverse events.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19455719
• Report Number: 3012236936-2024-000159
• Device Sequence Number: 20496317
• Product Code: HQL
• UDI-Device Identifier: 05050474660229
• UDI-Public: (01)05050474660229(17)250616
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 06/16/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U235
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2020
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White