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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 Codes Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event-unk.Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Occupation: was present in surgery-exact healthcare professional occupation unk.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a cq2015a intraocular lens, diopter +20.0 into the patient's eye on (b)(6) 2017.Reportedly, on (b)(6) 2017 the lens was exchanged with a same type, different diopter lens due to the patient being "unhappy with vision." the problem was 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 Key7201665
Report Number2023826-2018-00097
Device Sequence Number16397966
Product Code HQL
UDI-Device Identifier00841542101981
UDI-Public00841542101981
Combination Product (Y/N)N
Initial Reporter StatePA
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 company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/21/2017
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 Physician
Device Expiration Date06/30/2019
Device Model NumberCQ2015A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2017
Initial Report FDA Received Date01/17/2018
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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