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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED SIL. COATED I/A 45 STELLARIS 12/B; UNIT, PHACOFRAGMENTATION
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BAUSCH & LOMB INCORPORATED SIL. COATED I/A 45 STELLARIS 12/B; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number 85910ST
Device Problems Device Slipped (1584); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2023
Event Type  malfunction  
Event Description
Surgeon attempted to insert the i/a handpiece into the incision and the metal inner portion came out of the silicone sheath.He pulled handpiece out, ensured the metal was not outside the silicone and again attempted to insert with the same results.After multiple attempts, it was questioned whether there may be a defective hole in the sheath.A second i/a handpiece was opened, and it functioned as it should.The original handpiece was handed off the field.The case proceeded as planned.
 
Event Description
Surgeon attempted to insert the i/a handpiece into the incision and the metal inner portion came out of the silicone sheath.He pulled handpiece out, ensured the metal was not outside the silicone and again attempted to insert with the same results.After multiple attempts, it was questioned whether there may be a defective hole in the sheath.A second i/a handpiece was opened, and it functioned as it should.The original handpiece was handed off the field.The case proceeded as planned.
 
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Brand Name
SIL. COATED I/A 45 STELLARIS 12/B
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
400 somerset corporate blvd.
bridgewater NJ 08807
MDR Report Key16426531
MDR Text Key310053824
Report Number16426531
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number85910ST
Device Catalogue Number85910ST
Device Lot NumberFS22110085
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2023
Event Location Hospital
Date Report to Manufacturer02/23/2023
Type of Device Usage Unknown
Patient Sequence Number1
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