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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB, INC. TRULIGN INTRAOCULAR LENS
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BAUSCH & LOMB, INC. TRULIGN INTRAOCULAR LENS Back to Search Results
Model Number BL1UT
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2014
Event Type  Injury  
Event Description
It was reported that 3 days post lens implantation the lens was explanted due to mechanical complication.Another lens of a different model was implanted.Details of the mechanical complication were not provided.Additional information has been requested but no new information has been provided.
 
Manufacturer Narrative
Investigation is underway.A supplemental report will be submitted upon completion of the investigation.
 
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Brand Name
TRULIGN INTRAOCULAR LENS
Manufacturer (Section D)
BAUSCH & LOMB, INC.
rochester NY
Manufacturer Contact
sharon spencer
50 technology drive
irvine, CA 92618
9493985698
MDR Report Key4630192
MDR Text Key5570872
Report Number1313525-2015-00437
Device Sequence Number1
Product Code MJP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/19/2015
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 Expiration Date05/31/2019
Device Model NumberBL1UT
Device Lot Number7456327
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2015
Initial Date FDA Received03/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CRYSTALSERT DELIVERY DEVICE
Patient Age66 YR
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