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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STELLARIS POSTERIOR VITRECTOMY PACK
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BAUSCH & LOMB, INC. STELLARIS POSTERIOR VITRECTOMY PACK Back to Search Results
Catalog Number BL5323W
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2013
Event Type  malfunction  
Event Description
Report received from the (b)(6) which states: "the surgeon had commenced cutting the vitreous and suddenly the cutter stopped but started again a few seconds later only to stop again." no medical intervention/treatment was required.
 
Manufacturer Narrative
Product has been requested for evaluation.However, it has not yet been received.Sterilization and lot history records were reviewed and no exceptions were found.This report is related to the event reported on mdr 1920664-2013-00402, 00403 and 00405.
 
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Brand Name
STELLARIS POSTERIOR VITRECTOMY PACK
Manufacturer (Section D)
BAUSCH & LOMB, INC.
rochester NY 14609
Manufacturer Contact
sharon spencer, director global
30 enterprise
ste 450
alsio viejo, CA 92656
9493891786
MDR Report Key3853443
MDR Text Key4409759
Report Number1920664-2014-00404
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101325
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2014
Device Catalogue NumberBL5323W
Device Lot NumberV0624
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2013
Initial Date FDA Received04/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
STELLARIS EQUIPMENT (BAUSCH + LOMB)
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