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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED AKREOS AO LENS (RIGHT EYE); INTRAOCULAR LENS

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BAUSCH & LOMB INCORPORATED AKREOS AO LENS (RIGHT EYE); INTRAOCULAR LENS Back to Search Results
Model Number M160L
Patient Problems Visual Impairment (2138); Anxiety (2328)
Event Date 05/08/2013
Event Type  Injury  
Event Description
Reporter called to inform the fda that her implanted lenses in both right ((b)(6) 2013) and left ((b)(6) 2013) eyes have been recalled since 2014 and she was never informed of the recall.She learned about the recall today.To no avail, reporter stated that she informed the doctor immediately after being implanted that her vision was worse than what it was before, for both eyes.The implanted lenses have always given her problems with her vision but has escalated in the past year.Reporter stated that the recalled lenses are due to incorrect "raw material" used to manufacture the lenses and she would like to know more specifically what that entails and if it can cause loss of vision in the long term.Reference report: mw5151153.
 
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Brand Name
AKREOS AO LENS (RIGHT EYE)
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
BAUSCH & LOMB INCORPORATED
MDR Report Key18667414
MDR Text Key335069046
Report NumberMW5151152
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/07/2024
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? Yes
Device Model NumberM160L
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2024
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient SexFemale
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