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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION
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BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number BL5113
Device Problems Inability to Irrigate (1337); Device Damaged Prior to Use (2284); Infusion or Flow Problem (2964)
Patient Problems Eye Injury (1845); Eye Burn (2523)
Event Date 05/16/2017
Event Type  Injury  
Manufacturer Narrative
Product is not available for evaluation.Sterilization and lot history records were reviewed and no exceptions were found.
 
Event Description
The irrigation tubing was found to be bent upon opening of the pack, however the surgeon used it.During the procedure there was a loss of irrigation which resulted in a burn at the corneal incision.
 
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Brand Name
STELLARIS MICRO INCISION VACUUM PACK
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
Manufacturer Contact
juli moore
3365 treecourt industrial blvd
st. louis, MO 63122
6362263220
MDR Report Key6725685
MDR Text Key80458896
Report Number0001920664-2017-00251
Device Sequence Number1
Product Code HQC
UDI-Public(01)MISSING_UPC(17)180429
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Device Operator Health Professional
Device Expiration Date04/29/2018
Device Model NumberBL5113
Device Lot NumberV8317
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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