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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2,a3, a4 and a5: unknown/ not provided.Section b3: date of event: unknown, information not provided.Section d6a: if implanted, give date: unknown/ not provided.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the non-preloaded intraocular lens (iol) was explanted due to a patient unknown complaint.Procedure was completed with a non-j&j lens.The lens was discarded.No further information is available. .
Additional Manufacturer Narrative
Additional narratives/data: based on additional information received, the patient wanted to target near vision.Near vision was provided, but the patient then stated that they were not happy with the outcome and had wanted distance.The following section have been added to reflect the new information: section a2: age: 69 years.Section a3: date of birth: (b)(6)1955.Section a4: gender: female.Section a5: ethnicity: caucasian.Section d6a.If implanted, give date: (b)(6) 2024.Section d6b.If explanted, give date: (b)(6) 2024.Section h6: health effect - clinical code: 137 - blurred vision.Section e1: email address: (b)(6).All pertinent information available to johnson & 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: 21144143
• Report Number: 3012236936-2025-000008
• Device Sequence Number: 9602558
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)280307
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/07/2025

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000210
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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: 83 KG