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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 No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid in the lens vial.Visual inspection found the haptic torn.(b)(4).
 
Event or Problem Description
A cc4204a intraocular lens, diopter +25.5 was returned damaged.Attempts to obtain additional information have not been successful.
 
Additional Manufacturer Narrative
Work order search found no additional similar complaint type event(s) within the associate lots.Claim#: (b)(4).
 
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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 Key8127050
Report Number2023826-2018-01771
Device Sequence Number244352
Product Code HQL
UDI-Device Identifier00841542102506
UDI-Public00841542102506
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 company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/09/2018
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 Health Professional
Device Expiration Date12/31/2019
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2018
Initial Date Received by Manufacturer 11/09/2018
Supplement Date Received by Manufacturer02/12/2019
Initial Report FDA Received Date12/03/2018
Supplement Report FDA Received Date02/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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