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

Model Number	ZCB00
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens was implanted into the left eye of a female patient.During the procedure, the surgeon was unable to center the lens, which led to its explantation and replacement with another lens of the same model and diopter.The surgery was completed on the same day without causing harm to the patient, and the wound did not require enlargement or sutures.The platinum handpiece and cartridge were used, and the lens was loaded with room temperature amvisc, remaining in the viscoelastic for less than three minutes.No photos or videos of the event were available.The defective lens and cartridge were available for return, and no additional information was provided.
Additional Manufacturer Narrative
Section a3b, a4, a5 and a6: unknown, information not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.Section h3: 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 and complaint history for production order 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.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: sep 2, 2025 section h3: evaluated by manufacturer: yes device evaluation: visual inspection revealed the lens was received cut in half and stuck together.The lens was unstuck and cleaned revealing the lens was damaged and scratched; one haptic was detached.The complaint issue "positioning issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Manufacturing record review: the manufacturing records review for this production order shows that the units were released within specification.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.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: 22891813
• Report Number: 3012236936-2025-000225
• Device Sequence Number: 21056927
• Product Code: HQL
• UDI-Device Identifier: 05050474531758
• UDI-Public: (01)05050474531758(17)280315
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Female