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

Model Number	ZCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: implant date: not applicable, as lens was removed in the initial surgery.Section d6b: explant date: not applicable, as lens was removed in the initial surgery.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): the device was not returned for analysis; 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 h6- health effect - clinical code 4581: no code available (incision enlarged).Section h6 - medical device problem code - 3191: no code available (unspecified suspected product quality with patient involvement).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted and removed during implantation into the patient's eye.The cause is unknown and it is unknown if there was any patient injury.Surgery time was delayed.Incision was enlarged and sutures were required.Vitrectomy was performed and medication was prescribed.Surgery completed successfully with patient reported as fully recovered with no impact to vision.Vision pre-operative: 3/60 and vision post-operative: 6/12.No further information available.
Additional Manufacturer Narrative
Additional information received on november 11, 2025.The issue was related to haptic damaged.It was initially reported as: it was reported that an intraocular lens (iol) was inserted and removed during implantation into the patient's eye.The cause is unknown and it is unknown if there was any patient injury.Surgery time was delayed.Incision was enlarged and sutures were required.Vitrectomy was performed and medication was prescribed.Surgery completed successfully with patient reported as fully recovered with no impact to vision.Vision pre-operative: 3/60 and vision post-operative: 6/12.No further information available.

• 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: 17165944
• Report Number: 3012236936-2023-01503
• Device Sequence Number: 17596913
• Product Code: HQL
• UDI-Device Identifier: 05050474531758
• UDI-Public: (01)05050474531758(17)250827
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Expiration Date: 08/27/2025
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000220
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: Unknown