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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4, a5 and a6: unknown, information not provided.Section d6a: if implanted; give date: unknown, information not provided.Section d6b: if explanted; give date: not applicable as lens remained implanted.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: 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 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.Attempts were made to gather more information but no response was received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a crack was observed at the edge of the intraocular lens (iol) haptic after the lens had been implanted into the patient¿s eye.The iol was not replaced.The procedure was completed after the surgeon adjusted the lens position.There was no treatment delay and no additional interventions were required.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: 24500624
• Report Number: 3012236936-2026-000047
• Device Sequence Number: 21322260
• Product Code: HQL
• UDI-Device Identifier: 05050474636040
• UDI-Public: (01)05050474636040(17)270502
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: DCB0000180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: 43 YR
• Patient Sex: Male