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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 03/16/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.The lens was returned in liquid in lens vial.Visual inspection found one haptic torn.No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
A cc4204a collamer single piece lens, +21.5 diopter, was received by the manufacturer damaged.There was no patient contact.A backup lens was implanted and the problem was resolved.The cause of the event was unknown.
 
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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
MDR Report Key10310695
Report Number2023826-2020-01500
Device Sequence Number3416942
Product Code HQL
UDI-Device Identifier00841542102421
UDI-Public00841542102421
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P030016
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) 06/30/2020
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 Date09/30/2021
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/22/2020
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 Other;
Patient Age54 YR
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