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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY KS-NI2; INTRAOCULAR LENS
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STAAR SURGICAL COMPANY KS-NI2; INTRAOCULAR LENS Back to Search Results
Model Number KS-NI2 AQ310AIN 17.5
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Age, sex, weight, ethnicity, race: unk.Pma/510k- this product is not marketed in the us.(b)(4).Claim # (b)(4).
 
Event Description
The reporter indicated that when handling the rod of a ks-ni2 (b)(4), 17.5 diopter preloaded injector, the rod passed above iol and the optical part was blocked when handling the screw plunger and rod.There was no patient contact.
 
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Brand Name
KS-NI2
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
cynthia thai
1911 walker avenue
monrovia, CA 91016
8002927902
MDR Report Key12756572
MDR Text Key280472415
Report Number2023826-2021-04237
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model NumberKS-NI2 AQ310AIN 17.5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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