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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION

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AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number NGP680301
Device Problem Mechanical Problem (1384)
Patient Problem Eye Injury (1845)
Event Date 10/18/2023
Event Type  Injury  
Manufacturer Narrative
Unknown/ not provided.Serial number: unknown/not provided.Catalog#: unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi number: a complete udi # is unknown as product serial number was not provided.If implanted, give date: not applicable, as the phaco system is not implantable device.Section d6b: if explanted, give date: not applicable, as the phaco system is not implantable device.Device manufacture date: unknown as product serial number was not provided.Other (81): the phaco system 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.
 
Event Description
Customer reported that they had to do a vitrectomy on a patient and when they started, the vitrector was not cutting or aspirating.They lowered the cutting settings on the whitestar signature pro and it seemed to work a little.Through follow up it was reported by the account that the vitrectomy was unplanned.It was not reported what caused it.
 
Manufacturer Narrative
Correction: initial submission was submitted as an unknown lot number but it should have been lot number 60399739.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
It was reported that the devices were discarded and should not be expected.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
 
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Brand Name
WHITESTAR SIGNATURE PRO
Type of Device
UNIT, PHACOFRAGMENTATION
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 Key18531756
MDR Text Key333086090
Report Number3012236936-2024-00129
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNGP680301
Device Catalogue NumberNGP680301
Device Lot Number60399739
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/19/2023
Initial Date FDA Received01/17/2024
Supplement Dates Manufacturer Received02/22/2024
03/27/2024
Supplement Dates FDA Received03/20/2024
04/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
VITRECTOMY CUTTER LOT #60399739.
Patient Outcome(s) Required Intervention;
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