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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 Known Impact Or Consequence To Patient (2692)
Date of Event 10/27/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid in a case/vial.Visual inspection of the returned product found one haptic torn and a piece of the other haptic was torn off and missing.(b)(4).
 
Event or Problem Description
The reporter indicated the scrub technician accidently tore a cc4204a collamer single piece lens, +21.0 diopter, while loading, but it was not noticed until the lens was inserted and was removed immediately.There was no patient injury, no enlarged incision or sutures.Another lens of the same model and diopter was used.
 
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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 Key7065508
Report Number2023826-2017-01693
Device Sequence Number13648887
Product Code HQL
UDI-Device Identifier00841542102414
UDI-Public00841542102414
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
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/30/2017
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 Date08/31/2019
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2017
Initial Report FDA Received Date11/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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