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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 Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Lens was returned in liquid, in lens case/ vial.Visual inspection found foreign matter on the lens surface and half of the lens missing.No similar complaint events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the haptic of (b)(4) collamer three piece lens, +20.5 diopter, tore during insertion.It was reported that there was no surgical intervention and no patient injury.The back up lens was implanted within the same surgery with no issues.The reporter stated that the cause of the event was unknown.
 
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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 Key7177220
Report Number2023826-2018-00059
Device Sequence Number11209121
Product Code HQL
UDI-Device Identifier00841542101998
UDI-Public00841542101998
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
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/12/2017
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 Date12/31/2018
Device Model NumberCQ2015A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2017
Initial Report FDA Received Date01/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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