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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 Problems Adverse Event Without Identified Device or Use Problem; Optical Distortion
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative

The intraocular lens (iol) was returned without the original packaging. A large section of the iol and both plates have been torn off and are missing. Only about half of the iol was returned. Functional testing could not be performed due to the condition of the returned iol. The investigation of this event is in progress. Upon completion of the investigation, a follow up report will be submitted.

 
Event Description

It was reported that the intraocular lens (iol) was explanted from the patient's left eye and replaced five months post implant. The original procedure was not complicated in anyway. The orientation of the lens did not change and the optic was free and clear of debris/deposits, however the patient did notice a decrease in his vision. The patient experienced blurry vision, glare at night, hard to read street signs, and had halos. The trulign bl1ut2200125 was exchanged and replaced with a different model of the same diopter. In the surgeon's opinion, the likely cause of the event is positive dysphotopsia and the patient's prognosis is excellent. Symptoms resolved with the replacement envista toric lens.

 
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Brand NameTRULIGN TORIC POSTERIOR CHAMBER IOL
Type of DeviceLENS, 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
stephanie anastasiou
221 north park pl blvd
clearwater , FL 33759
7277246659
MDR Report Key8939113
Report Number0001313525-2019-00129
Device Sequence Number1
Product CodeMJP
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/01/2005,07/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device MODEL NumberBL1UT
Device Catalogue NumberBL1UT2200125
Device LOT Number7556013
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received09/09/2019
Is this a Reprocessed and Reused Single-Use Device? No

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