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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SND1T4
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/28/2018
Event Type  Injury  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There have been no other complaints reported in the lot number. Additional information has been requested. (b)(4).
 
Event Description
An ophthalmologist reported that three weeks following an intraocular lens (iol) implant procedure, the iol was exchanged for another lens of the same model, but one diopter more power. The reason given was refraction error. Additional information has been requested.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The lens was returned in lens case which is different from the reported complaint serial number. Blood and solution is dried on the lens. Both haptics are bent in the gusset and distal area. The optic is cut into two portions, typical of insertion and removal. One cut optic portion has a chipped optic edge with lens material missing (not returned). Power and resolution testing could not be conducted due to the extensive optic damage. The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter. Product history records were reviewed and the documentation indicated the product met release criteria. Associated products were not provided. It is unknown if qualified products were used. The product investigation could not identify a root cause for the reported complaint. Power and resolution testing could not be conducted due to the extensive optic damage. The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter. (b)(4).
 
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Brand NameACRYSOF RESTOR TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key7942923
MDR Text Key123058202
Report Number1119421-2018-01450
Device Sequence Number0
Product Code MJP
PMA/PMN Number
P040020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/30/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Model NumberSND1T4
Device Catalogue NumberSND1T4.220
Device Lot Number12457451
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/08/2018 Patient Sequence Number: 1
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