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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 06/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter stated that a haptic of a cc4204a intraocular lens, +26.5 diopter, was torn.It was noticed by the scrub technician during loading.No patient contact.Backup lens was implanted.
 
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a lens vial.Visual inspection found the optic and haptic torn.Claim#: (b)(4).
 
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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 Key8827109
Report Number2023826-2019-01308
Device Sequence Number2654428
Product Code HQL
UDI-Device Identifier00841542102520
UDI-Public00841542102520
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 07/01/2019
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 Date11/30/2019
Device Model NumberCC4204A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Initial Date Received by Manufacturer 07/01/2019
Supplement Date Received by Manufacturer08/29/2019
Initial Report FDA Received Date07/25/2019
Supplement Report FDA Received Date09/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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