MAUDE Adverse Event Report: STAAR SURGICAL COMPANY KS-1; INTRAOCULAR LENS

Model Number KS-1 AQ2017V

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

Reportedly, as the surgeon was pushing the rod forward of a ks-1 aq2017v intraocular lens diopter +21.5 the trailing haptic was abnormal at the waiting position.The lens was not used and the backup preloaded system was used.This occurred on (b)(6) 2021.There was no patient contact with this lens.

Manufacturer Narrative

Additional information: h3.Device evaluation:returned sample was confirmed that rear haptic deformed due to lens twisted.It was confirmed that returned sample was filled appropriately volume of viscoelastic material by injected mark.It was confirmed that the top flange was pushed down correctly.Claim# (b)(4).

• Brand Name: KS-1
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 12102550
• MDR Text Key: 259601969
• Report Number: 2023826-2021-02133
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: KS-1 AQ2017V
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1