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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS LENS, INTRAOCULAR, TORIC OPTICS

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BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number MX60ET
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative
The lens was returned for evaluation. Visual inspection found the lens cut or torn, with one haptic attached to the optic and the other haptic is missing. The device history record (dhr) was reviewed, and there were no discrepancies or anomalies related to the reported issue. The trend analysis, risk analysis, and directions for use review are considered acceptable, with the product performing within anticipated rates. Based on the available information, user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.
 
Event Description
It was reported the intraocular lens (iol) was implanted into the patient¿s right eye (od) and was found to have a sheared haptic. It was unclear if this happened during loading of the iol or implant. Incision was enlarged to remove the lens with the use of lens cutters. Another lens of the same model and diopter was successfully implanted. Sutures were required to close.
 
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Brand NameENVISTA TORIC INTRAOCULAR LENS
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
shayan habibi
21 north park place blvd.
clearwater, FL 33759
MDR Report Key12373714
MDR Text Key268341703
Report Number0001313525-2021-00111
Device Sequence Number1
Product Code MJP
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P910056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMX60ET
Device Catalogue NumberMXUET350+245
Device Lot Number222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2021
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/26/2021 Patient Sequence Number: 1
Treatment
BAUSCH AND LOMB INJECTOR SYSTEM (BLIS)
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