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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS
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STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS Back to Search Results
Model Number CC4204A +20.5
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that a cc4204a +20.5 diopter, intraocular lens was difficult to load.The surgeon noted a tear in the lens when he placed it into the patients eye.The lens was removed immediately and replaced with the backup lens, no patient injury was reported.Cause of event is unknown.
 
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Brand Name
SEE H10
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key9901239
Report Number2023826-2020-00719
Device Sequence Number2437849
Product Code HQL
UDI-Device Identifier00841542102407
UDI-Public00841542102407
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P990013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/02/2020
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 Health Professional
Device Expiration Date03/31/2021
Device Model NumberCC4204A +20.5
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2020
Initial Report FDA Received Date03/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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