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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation as it remains implanted; 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.An attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded monofocal intraocular lens (iol) edge appear to be was frayed.The iol remains implanted.Through follow up it was learned that there was no patient injury and no medical or surgical intervention performed.The patient outcome is unknown.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr, it was noticed that the following information was inadvertently not included; therefore, it is captured in this supplemental report: the iol was fully inserted and remains implanted.The product is not available for return.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the suspect product was not received; however, a photo was provided by the customer.Product evaluation was performed on a photograph the customer provided.The photo displays an eye being implanted with an intraocular lens claimed to be a tecnis eyhance iol preloaded in the simplicity delivery system (model dib00).An irregularity and roughness can be observed in the lens edge at 2 locations.There is a red circulated portion of the lens edge in the photo.Per the location of the reported and observed issue, it is not expected to cause any clinical impact; however, the definitive clinical impact and the issue potential root cause cannot be determined from a picture assessment.Since no product has been received, no further evaluation has been performed.The complaint issue " lens damaged" was identified during photo evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 21334621
• Report Number: 3012236936-2025-000030
• Device Sequence Number: 17105955
• Product Code: HQL
• UDI-Device Identifier: 05050474731660
• UDI-Public: (01)05050474731660(17)261207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 05/16/2025

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: DIB00
• Device Catalogue Number: DIB00U0155
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 04/21/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/07/2025; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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 Sex: Unknown