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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB TRULIGN TORIC POSTERIOR CHAMBER IOL; LENS, INTRAOCULAR, TORIC OPTICS

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BAUSCH + LOMB TRULIGN TORIC POSTERIOR CHAMBER IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number BL1UT
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Visual Impairment (2138); Fibrosis (3167)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported that a patient experienced a lens positioning change in the left eye four months post-cataract surgery.Regarding pre-existing ocular conditions, it was noted that the patient had previously undergone radial keratotomy (rk) surgery.During the cataract surgery, the surgeon had to use two 10-0 sutures to close the wound due to the previous rk surgery cuts.One of the sutures was radial and the other was circumferential so as to close the gap between the rk surgery incisions.It was specified that the implanted lens vaulted in the posterior direction.In addition, one of the lens platforms came out of the capsular bag in the anterior direction, forming an "l" shape.The lens platform that remained in the capsular bag became "fibrosed," though the haptics remained free.The patient had also noticed a decrease in their vision.A lens exchange was performed twelve days after onset.The patient is expected to return to the clinic for ongoing evaluation and care.
 
Manufacturer Narrative
The lens was not returned for evaluation.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, the root cause of the reported could not be determined.
 
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Brand Name
TRULIGN TORIC POSTERIOR CHAMBER IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
BAUSCH + LOMB
1400 north goodman street
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB
21 north park place blvd.
clearwater FL 33759
Manufacturer Contact
faranak gomarooni
50 technology drive west
irvine, CA 92618
9493985708
MDR Report Key7162871
MDR Text Key96319753
Report Number0001313525-2018-00006
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 company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/08/2017
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 Physician
Device Expiration Date07/31/2020
Device Model NumberBL1UT
Device Catalogue NumberBL1UT2150275
Device Lot Number7558009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received01/03/2018
Supplement Dates Manufacturer Received01/25/2018
Supplement Dates FDA Received01/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
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