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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 +16.5
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2020
Event Type  Injury  
Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).
 
Event Description
The reporter indicated that a cc4204a, +16.5 diopter, intraocular lens was inserted into the patients eye and the doctor felt it was too tight.The lens was removed and replaced with a different lens, no patient complication noted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
 
Manufacturer Narrative
H3- device evaluation : lens was returned in liquid, inside vial.Lens was returned in pieces, unable to evaluate.(b)(4).
 
Manufacturer Narrative
Claim#: (b)(4).
 
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Brand Name
SEE H10
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key10338047
MDR Text Key200817319
Report Number2023826-2020-01602
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00841542102322
UDI-Public00841542102322
Combination Product (y/n)N
PMA/PMN Number
P990013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 06/30/2020
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? Yes
Device Operator Health Professional
Device Model NumberCC4204A +16.5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/29/2020
Supplement Dates Manufacturer Received08/18/2020
12/29/2020
Supplement Dates FDA Received09/19/2020
12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK.
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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