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	Visual Disturbances (2140)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a5, a6: unknown, not provided.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information, a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a non-preloaded, monofocal intraocular lens (iol) was explanted from a patient's left eye due to mechanical complications and the occurrence of optical apparitions in the patient.The procedure was completed using a non-johnson & johnson replacement lens.No additional surgical interventions, such as vitrectomy, sutures, or incision enlargement, were required.The patient's outcome was reported as stable.No further information provided.
Additional Manufacturer Narrative
Additional information: additional information provided indicated that no medication outside the standard of care required and that the email of the doctor is (b)(6).No further information was provided.D9: device available for evaluation: yes.D9: date returned to manufacturer: nov.05, 2025.H3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut in half and coated in an unknown liquid.The lens was cleaned revealing the lens was damaged and had a detached haptic.The physical characteristics of the lens were confirmed to match that of a zcb00 model lens.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: it was noticed that the email (b)(6) was inadvertently entered in the section "e1" of the initial mdr report which is incorrect.This supplemental mdr report captures the correct email address for doctor and the following field was updated accordingly: section e1: email:(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: 23341507
• Report Number: 3012236936-2025-000271
• Device Sequence Number: 7677574
• Product Code: HQL
• UDI-Device Identifier: 05050474531642
• UDI-Public: (01)05050474531642(17)290110
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/15/2025

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: ZCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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 Sex: Female
• Patient Weight: 69 KG