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

Model Number	DCB00
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, a5, a6: information unknown/not provided.Section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted; give date: not applicable, there is no indication the lens has been explanted.Section e1: telephone number: (b)(6).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 trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt to obtain additional information was conducted, however, there is no additional information available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) was expanded prematurely while being ejected from the cartridge, which obstructed its passage through the 2.4mm corneal incision.The report indicated that the device came into contact with the patient.As a result, a replacement lens was necessary to complete the procedure.Through follow up, it was learned how the device was prepared.The lens preparation involved the use of balanced salt solution (bss) at room temperature, which was filled through the hydration port and stored in the cartridge for 15 seconds to one minute before being handed to the surgeon.The nurse initially advanced the lens into the cartridge, and no unusual resistance was noted during this process.The customer observed that this issue is rare and suggested it may be related to the manner in which the leading haptic tucks into the folded optic.No additional surgical maneuvers, unplanned interventions, or medications were required.There was no patient injury.The patient outcome was reported as very good.No further information was provided.

• Brand Name: TECNIS SIMPLICITY
• 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: 25119695
• Report Number: 3012236936-2026-000111
• Device Sequence Number: 10642684
• Product Code: HQL
• UDI-Device Identifier: 05050474636187
• UDI-Public: (01)05050474636187(17)270909
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: DCB00
• Device Catalogue Number: DCB0000250
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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: 37 YR
• Patient Sex: Female