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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON LABORATORIES IRELAND LTD. ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60WF
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported a folding issue with an intraocular lens (iol).There was reported patient contact but no reported patient impact.Additional information was requested.
 
Manufacturer Narrative
The product was returned for analysis.Additional information: the lens was returned just past the loading area in a iii (d) cartridge.Inadequate viscoelastic is observed in the cartridge.The trailing haptic is extended back behind the lens.The leading haptic is folded back toward the optic.The cartridge has no evidence of being placed into a handpiece.The cartridge was cleaned for further evaluation.The lens was removed and placed in the lens case.Top coat dye stain testing was conducted with acceptable results.The root cause for the reported complaint appears to be related to a failure to follow the dfu.No viscoelastic was observed past the lens.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
MDR Report Key8607479
MDR Text Key144971155
Report Number9612169-2019-00100
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberSA60WF
Device Catalogue NumberSA60WF.225
Device Lot Number21224952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Initial Date Manufacturer Received 04/24/2019
Initial Date FDA Received05/14/2019
Supplement Dates Manufacturer Received08/30/2019
Supplement Dates FDA Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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