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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS
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STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS Back to Search Results
Model Number CC4204A
Medical Device Problem Code Torn Material (3024)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/19/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Claim # (b)(4).
 
Event or Problem Description
The reporter stated the surgeon inserted a cc4204a collamer single piece lens, +20.5 diopter, and the lens tore.The lens was partially inserted and was removed within the same surgery, with no patient injury.The backup lens was implanted.The reporter stated the lens was not folded properly during the loading process and the cause of the event was due to user/technique error.
 
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Brand Name
SEE H-10
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key6089923
Report Number2023826-2016-01610
Device Sequence Number16333156
Product Code HQL
UDI-Device Identifier00841542102407
UDI-Public(01)00841542102407(17)180430
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
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/31/2016
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 Date04/30/2018
Device Model NumberCC4204A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2016
Initial Report FDA Received Date11/09/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CARTRIDGE MODEL NANOPOINT - LOT NUMBER UNK; INJECTOR MODEL NANOPOINT - LOT NUMBER UNK
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