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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SN60WF
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Rupture (2208)
Event Date 03/11/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.This product malfunction was originally reported under a voluntary summary report.New information was received which prompts assessment and expedited reporting.The updated information is being sent via this 3500a report.(b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, when they went to deploy the iol it malfunctioned.Additional information was provided that the capsule ruptured during the initial procedure.
 
Manufacturer Narrative
Product evaluation: the lens was returned in a qualified cartridge.Viscoelastic is observed in the cartridge.The lens is advanced between the loading area and the nozzle entry area.The lens and haptic positions are acceptable for advancement.The cartridge has evidence it was placed into a handpiece.No damage observed.All product and batch history records are quality reviewed prior to product release.No problem was found with the returned iol.The lens was returned advanced in a cartridge.The lens and haptic positions were acceptable for advancement.No damage was observed.It was initially reported that the iol malfunctioned.New information on the iol card states not implanted wasted - capsule ruptured.The lens could not have contributed to a capsule rupture as it has not been delivered.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ACRYSOF IQ NATURAL SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key10040698
MDR Text Key190474232
Report Number1119421-2020-00757
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 other
Type of Report Initial,Followup
Report Date 06/26/2020
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 Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberSN60WF
Device Catalogue NumberSN60WF.245
Device Lot Number12704227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Initial Date Manufacturer Received 04/13/2020
Initial Date FDA Received05/08/2020
Supplement Dates Manufacturer Received06/02/2020
Supplement Dates FDA Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MONARCH III D CARTRIDGES
Patient Outcome(s) Other;
Patient Age69 YR
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