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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 +17.5
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens no similar complaint type events were reported for units within the same lot.Lens was returned in vial, in liquid.Visual inspection found no visible damage to lens.(b)(4).
 
Event or Problem Description
The reporter indicated that a haptic of a cq2015a, +17.5 diopter, intraocular lens bent during loading on (b)(6) 2018 with no paitent contact.Backup lens was implanted.The problem resolved.
 
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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 Key8028718
Report Number2023826-2018-01541
Device Sequence Number1434798
Product Code HQL
UDI-Device Identifier00841542101936
UDI-Public00841542101936
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 health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/09/2018
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 Date06/30/2019
Device Model NumberCQ2015A +17.5
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2018
Initial Report FDA Received Date11/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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