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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 +21.5
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/28/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical product: collamer ultraviolet-absorbing posterior chamber three 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 a haptic of a cq2015a, +19.5 diopter, intraocular lens tore due to override on advancement of injector.It was reported that there was no patient contact.Backup lens used.
 
Additional Manufacturer Narrative
(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 Key7888979
Report Number2023826-2018-01319
Device Sequence Number1837544
Product Code HQL
UDI-Device Identifier00841542102018
UDI-Public00841542102018
Combination Product (Y/N)N
Initial Reporter StateCA
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 Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/28/2018
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 Date06/30/2019
Device Model NumberCQ2015A +21.5
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/28/2018
Supplement Date Received by Manufacturer11/26/2018
Initial Report FDA Received Date09/19/2018
Supplement Report FDA Received Date11/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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