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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SENSAR; MONOFOCAL IOLS
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ABBOTT MEDICAL OPTICS SENSAR; MONOFOCAL IOLS Back to Search Results
Model Number AR40E
Medical Device Problem Codes Folded (2630); Unintended Movement (3026)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).All pertinent information available to the manufacturer has been submitted.
 
Event or Problem Description
It was reported a customer experienced problems with an ar40e intraocular lens (iol).It was noted that the lens was defective with haptic folded.The iol was displaced and was explanted.There was no delay in the procedure.Furthermore, the device is not available for investigation.Patient pre-operatory details and patient outcome was also not available.
 
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Brand Name
SENSAR
Common Device Name
MONOFOCAL IOLS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
MDR Report Key6375328
Report Number2648035-2017-00399
Device Sequence Number1008190
Product Code HQL
UDI-Device Identifier05050474502239
UDI-Public(01)05050474502239(17)160729
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
P980040
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2013
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/02/2017
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
Operator of Device Physician
Device Expiration Date07/29/2016
Device Model NumberAR40E
Device Catalogue NumberAR40E00270
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/06/2017
Initial Report FDA Received Date03/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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