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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/15/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Collamer® ultraviolet-absorbing posterior chamber single piece foldable intraocular lens (b)(4).
 
Event or Problem Description
The reporter indicated the surgeon inserted and removed a cc4204a collamer single piece lens, +21.5 diopter, during the same surgery due to weak zonule and a thicker lens was required.The incision was enlarged to remove the lens and sutures were required to close.The reporter indicated the cause of the event was due to minor pre-existing condition and was patient related.The reporter indicated there was no issue with the product.The lens was discarded at the facility.
 
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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 Key6917430
Report Number2023826-2017-01518
Device Sequence Number1041724
Product Code HQL
UDI-Device Identifier00841542102421
UDI-Public00841542102421
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
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date05/31/2019
Device Model NumberCC4204A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2017
Initial Report FDA Received Date10/05/2017
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 Required Intervention;
Patient Age66 YR
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