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 Corneal Perforation (1792)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Section h3: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that one of the anterior penetrating arcuates fully penetrated the patients cornea due to patient movement.Doctor noticed this when he injected medication in the patient's eye.Doctor sutured the incision and completed procedure successfully.No additional information was provided.

Manufacturer Narrative

Correction: section h4: correction: in initial report, the manufacturer date provided was inadvertently reported as jan 12, 2017, however the correct date is jan 10, 2017.Additional information/device evaluation: section h3: device evaluated by manufacturer - yes.Section h4: correction: in initial report, the manufacturer date provided was inadvertently reported as oct 4, 2021, however the correct date is oct 7, 2021.Section h6; type of investigation - 3331, 4109.Section h6; investigation findings - 213.Section h6; investigation conclusions - 67.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17099115
• MDR Text Key: 316938980
• Report Number: 3012236936-2023-01443
• 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,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White