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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
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 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 the surgeon loaded a cc4204a implantable collamer lens, +21.5 diopter and the lens tore.There was no patient contact.The surgeon decided to implant a non staar lens.The reporter stated that the cause of event was 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 91016
MDR Report Key7359984
Report Number2023826-2018-00462
Device Sequence Number11152099
Product Code HQL
UDI-Device Identifier00841542102421
UDI-Public00841542102421
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) 02/23/2018
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? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/23/2018
Initial Report FDA Received Date03/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age58 YR
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