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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

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BAUSCH + LOMB ENVISTA INTRAOCULAR LENS Back to Search Results
Model Number MX60PL
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Unspecified Eye / Vision Problem (4471)
Event Date 02/09/2021
Event Type  Injury  
Manufacturer Narrative
Though requested, the device has not been returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.According to the available information, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.
 
Event Description
It was reported that during implantation of an intraocular lens (iol) into the left (os) eye, it was noticed intraoperatively that the trailing haptic was severed.The incision original size of 2.4mm was enlarged to 3.0mm for iol removal.A successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Sutures were required.The patient did not notice a decrease in vision at the 1 week post op visit.In the surgeon's opinion, the most likely cause of the iol damage was the lens getting stuck between the cartridge and the plunger.The patient's outcome is good.
 
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Brand Name
ENVISTA INTRAOCULAR LENS
Type of Device
INTRAOCULAR LENS
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
21 north park place blvd.
clearwater, FL 33759
MDR Report Key11574355
MDR Text Key252314797
Report Number0001313525-2021-00034
Device Sequence Number1
Product Code HQL
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 distributor,user facility
Reporter Occupation Physician
Type of Report Initial
Report Date 02/09/2021
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 Date08/31/2023
Device Model NumberMX60PL
Device Catalogue NumberMXUEPL1750
Device Lot Number222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/09/2021
Initial Date FDA Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2020
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) Required Intervention;
Patient Age75 YR
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