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

Model Number CATALYS-I

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Corneal Perforation (1792)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6) section h3 - other (81): the catalys machine was not evaluated.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the use of the catalys machine, the patient had an incision that went completely through the cornea.The territory manager (tm) reported that the last image from the optical coherence tomography (oct) scan appears to show that the oct did not fit to the real surfaces, and that this was not a problem of eye movement.The patient is okay and no specific action is needed.No additional information was received.

Manufacturer Narrative

Correction: h4: correction: in initial report, the manufacturer date provided was inadvertently reported as nov 25, 2014, however the correct date is oct 07, 2014.Additional information: device evaluation: product evaluation was performed for this incident by the engineer via remote support (technical service).No malfunctions were found during evaluation by remote support (technical service).Probable cause: the picture was reviewed by the engineer and appeared that the user should have the surface-fit adjusted.This instruction is usually trained by clinical.The dav (daily alignment verfication) is showing a perfect result which means that the system is in perfect condition.An intensive clinical training was done by the application support manager with several follow-up visits.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 18135934
• MDR Text Key: 328108053
• Report Number: 3012236936-2023-02735
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K113479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CATALYS-I
• Device Catalogue Number: CATALYS-I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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
• Patient Outcome(s): Other