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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 No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens and plunger tip were returned stuck in a cartridge.There was residue on the lens.No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated a cc4204a collamer single piece lens, +22.5 diopter, crumpled and there was no patient contact.The reporter indicated they have some new nurses that are learning the system.The reporter was unable to provide any additional information.
 
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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 Key8438560
Report Number2023826-2019-00428
Device Sequence Number18891938
Product Code HQL
UDI-Device Identifier00841542102445
UDI-Public00841542102445
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
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/18/2019
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 Date06/30/2020
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2019
Initial Report FDA Received Date03/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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