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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The reporter indicated that a (b)(4) collamer single piece lens, +17.5 diopter, was wasted and the surgeon ended up implanting a non-staar lens.Additional information has been requested but none has been forthcoming.If additional information is received , a supplemental medwatch report will be submitted.
 
Additional Manufacturer Narrative
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 Key7169802
Report Number2023826-2018-00029
Device Sequence Number13909026
Product Code HQL
UDI-Device Identifier00841542102346
UDI-Public00841542102346
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P990013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/06/2017
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 Date09/30/2018
Device Model NumberCC4204A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/06/2017
Supplement Date Received by Manufacturer03/06/2018
Initial Report FDA Received Date01/05/2018
Supplement Report FDA Received Date03/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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