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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 CC4204A
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pt info: unk.Collamer ultraviolet-absorbing posterior chamber single 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 on (b)(6) 2018 a cc4204a, +19.5 diopter, intraocular lens tore on loading.There were no problems during loading, advancement of the lens, or unusual events that led to the tear.It was reported that there was no patient contact.The back-up lens was implanted intraoperatively.
 
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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 Key8159590
Report Number2023826-2018-01836
Device Sequence Number2203542
Product Code HQL
UDI-Device Identifier00841542102384
UDI-Public00841542102384
Combination Product (Y/N)N
Initial Reporter StateNC
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) 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/29/2020
Device Model NumberCC4204A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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