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U.S. Department of Health and Human Services

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

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AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER Back to Search Results
Model Number CATALYS-I
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Bag Tear (2639)
Event Date 02/08/2023
Event Type  Injury  
Event Description
It was reported there was a capsule tear during the phacoemulsification procedure.There was unplanned vitrectomy performed on the patient.There was no delay in treatment or other interventions performed.No further information was provided.
 
Manufacturer Narrative
Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable, as lens was not implanted.Explant date not applicable, as lens was not implanted.Initial reporter telephone number: (b)(6).The device was not returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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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 Key16845389
MDR Text Key314303006
Report Number3012236936-2023-00844
Device Sequence Number1
Product Code OOE
UDI-Public(01)
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K113479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCATALYS-I
Device Catalogue NumberCATALYS-I
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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