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 Problems Hyphema (1911); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

Section a4 and a5: unknown, requested not provided.Section d6a: if implanted, give date: not applicable, as catalys system is not an implantable device.Section d6b: if explanted, give date: not applicable, as catalys system is not an implantable device.Device evaluation: the catalys system was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.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 that they successfully completed a capsularrhexis on their catalys system.The equipment indicated that a capsularrhexis was completed and the medical doctor indicated it wasn¿t.Per follow up, the doctor stated that he knew it was going to be a tough case.Patient had a small non-uniform pupil, the doctor made manual adjustments to the pupil/iris surface map.Planned capsulotomy diameter was 4.3mm.Doctor successfully completed the catalys procedure.When the patient was brought to the operating room for the cataract removal, doctor noted a hyphema.Doctor used trypan blue to stain the anterior capsule, he was unable to visualize the capsulotomy.Therefore, doctor successfully created a manual capsulotomy.Cataract was removed and intraocular lens iol implanted successfully.No patient injury reported.Doctor was frustrated with the additional time that was required to complete the case.No further information provided.

Manufacturer Narrative

H10.Additional data - section a3, gender - male.Section a4, patient weight - 95 kilogram(s).All pertinent information available to johnson & 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18080896
• MDR Text Key: 327481547
• Report Number: 3012236936-2023-02787
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 95 KG