MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number CATALYS-U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: information was requested and it was not provided.Section d6a: if implanted, give date: not applicable, as laser is not an implantable device.Section d6b: if explanted, give date: not applicable, as laser is not an implantable device.Device evaluation: remote support confirmed that the system is performing as intended.No issues identified.Therefore, the reported issue could not be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that there was one [1] discrepancy or non-conformance experienced during manufacturing.The system and its components met all specifications prior to being released.A search revealed that no additional complaints of unspecified injury were received from this laser system.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported utilizing the capsulotomy and fragmentation incisions on their catalys system.The physician performed an anterior vitrectomy after removing the cortex.Lens was implanted as intended.After the case, the physician commented that it wasn¿t due to the laser.No further information provided.

• Brand Name: CATALYS SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; unknown; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17920843
• MDR Text Key: 325500474
• Report Number: 3012236936-2023-02564
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Device Identifier: 05050474609792
• UDI-Public: (01)05050474609792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CATALYS-U
• Device Catalogue Number: CATALYS-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1