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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS PRELOADED

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BAUSCH + LOMB ENVISTA INTRAOCULAR LENS PRELOADED Back to Search Results
Model Number MX60PL
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2022
Event Type  Injury  
Manufacturer Narrative
As per the reporter, the device has been discarded and is not available for analysis.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all the available information, the root cause of this event could not be determined.
 
Event Description
Reportedly, during an intraocular lens (iol) implant procedure there was difficulty injecting the lens and a crack was noticed in the centre of the lens optic when in the patient¿s eye.The iol was removed and replaced intraoperatively with another iol of the same model and diopter.The incision size was enlarged to 5mm to remove the iol and sutures were required.The patient outcome was not compromised.Additional information was requested but not received.
 
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Brand Name
ENVISTA INTRAOCULAR LENS PRELOADED
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
shayan habibi
21 north park place blvd.
clearwater, FL 33759
7277246600
MDR Report Key15408538
MDR Text Key299767883
Report Number0001313525-2022-00117
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P910056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2022
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 Model NumberMX60PL
Device Catalogue NumberMXPL2150
Device Lot Number3241909
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2022
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
ENVISTA SIMPLIFEYE INSERTER
Patient Outcome(s) Required Intervention;
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