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 Code	Zonular Dehiscence (2698)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two non-preloaded monofocal intraocular lenses (iols) were attempted but not implanted in the patient¿s left eye (os), resulting in the patient leaving surgery aphakic.Initially, an attempt was made to implant a zcb00 model lens in the sulcus of the left eye and the lens was fully inserted; however, the iol was unstable in sulcus and the zonules were noted to be unstable/loose.As a result, the lens was removed and an unplanned anterior vitrectomy was performed.The pre-operative best spectacle-corrected visual acuity (bscva) was reported as 20/25-3.Subsequently, an attempt was made to implant an ar40e lens as an anterior chamber iol (aciol) in the left eye.During this attempt, patient movement occurred and an iris dialysis with sphincter tear was reported.The iol was removed, and no additional interventions were performed.No replacement iol was implanted, and the patient was sent home aphakic.Although sutures were initially indicated, follow-up with the account confirmed that no additional interventions were required.No further information was provided.This report pertains to the lens model zcb00.A separate report will be submitted for the ar40e model lens.
Additional Manufacturer Narrative
Attempts were made to obtain additional information regarding the event; however, the information was not provided.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: 24948364
• Report Number: 3012236936-2026-000104
• Device Sequence Number: 21355567
• Product Code: HQL
• UDI-Device Identifier: 05050474531796
• UDI-Public: (01)05050474531796(17)291013
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: ZCB0000240
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American