• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE PRO; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number NGP680301
Device Problem Reflux within Device (1522)
Patient Problems Eye Burn (2523); Zonular Dehiscence (2698)
Event Type  Injury  
Manufacturer Narrative
Date of event: date unknown/ not provided.Telephone number: (b)(6).Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Event Description
A glaucoma specialist reported that is unsatisfied with our machine at present.The specialist reported the following, general issues and decided to for now suspend use of this machine and use the second machine they have on site: many burns at the incision.Chamber instability.Unexpected reflux.No specific details were provided and no interventions reported.No additional information was provided.
 
Manufacturer Narrative
Device evaluation: the whitestar signature pro was not made available for evaluation.Therefore, a failure analysis of the complaint device could not be performed.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.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.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for whitestar signature pro system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
510 cottonwood drive
milpitas, CA 95035
7142478552
MDR Report Key11735179
MDR Text Key247626643
Report Number3006695864-2021-07564
Device Sequence Number1
Product Code HQC
UDI-Device Identifier05050474596146
UDI-Public(01)05050474596146
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K151636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/24/2021
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/27/2021
Supplement Dates Manufacturer Received04/28/2021
Supplement Dates FDA Received05/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2020
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) Other;
-
-