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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 Known Impact Or Consequence To Patient (2692)
Date of Event 10/22/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Implanted: unk.Explanted: unk.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the haptic of a cc4204a, +20.5 diopter, intraocular lens had a tear.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
 
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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 Key9416955
Report Number2023826-2019-02293
Device Sequence Number18953664
Product Code HQL
UDI-Device Identifier00841542102407
UDI-Public00841542102407
Combination Product (Y/N)N
Initial Reporter StateIL
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 Nurse
Type of Report Initial
Report Date (Section B) 11/11/2019
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 Date01/31/2021
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 11/11/2019
Initial Report FDA Received Date12/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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