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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS
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STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS Back to Search Results
Model Number CC4204A
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned dry, in lens vial.Visual inspection found a small piece of lens returned, the rest of the lens was missing.There was residue on the lens.(b)(4).
 
Event or Problem Description
The reporter indicated the surgeon was inserting a cc4204a collamer single piece lens, +22.5 diopter and noted the lens was torn.There was patient contact but no injury.The backup lens was implanted.The reporter indicated the surgeon stated the lens was loaded incorrectly and was due to a loading error.
 
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Brand Name
SEE H-10
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key7527867
Report Number2023826-2018-00755
Device Sequence Number1438672
Product Code HQL
UDI-Device Identifier00841542102445
UDI-Public00841542102445
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P990013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/23/2018
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
Operator of Device Physician
Device Expiration Date10/31/2019
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2018
Initial Report FDA Received Date05/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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