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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CATARACT EYE LENS; INTRAOCULAR LENS

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BAUSCH & LOMB INCORPORATED CATARACT EYE LENS; INTRAOCULAR LENS Back to Search Results
Model Number MI60L
Device Problem Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 08/26/2021
Event Type  Injury  
Event Description
Have a defective cataract lens that has blurred my vision because of calcification of the lens.My eye doctor has never seen this in a patient and only read about it in text book.Very rare condition.Fda safety report id# (b)(4).
 
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Brand Name
CATARACT EYE LENS
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
MDR Report Key12638972
MDR Text Key276914346
Report NumberMW5104654
Device Sequence Number1
Product Code HQL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/12/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMI60L
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/14/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight113
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