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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 CQ2015A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Device evaluation: the lens was returned in liquid in the lens case/vial.Visual inspection found the haptic and optic torn.(b)(4).
 
Event or Problem Description
The reporter indicated that, a cq2015a intraocular lens, diopter +21.0 was "implanted and removed." fail date reported as (b)(6) 2018.Attempts to obtain additional information have not been successful.
 
Additional Manufacturer Narrative
Additional data: work order search: no similar complaint type events were reported for units within the same lot.(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 Key8107283
Report Number2023826-2018-01720
Device Sequence Number2112337
Product Code HQL
UDI-Device Identifier00841542102001
UDI-Public00841542102001
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P990013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/31/2019
Device Model NumberCQ2015A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Initial Date Received by Manufacturer 11/02/2018
Supplement Date Received by Manufacturer02/01/2019
Initial Report FDA Received Date11/27/2018
Supplement Report FDA Received Date02/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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