MAUDE Adverse Event Report: STAAR SURGICAL COMPANY KS-NI2; INTRAOCULAR LENS

Model Number AQ310AIN

Device Problems Partial Blockage (1065); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

The reporter indicated the surgeon attempted to use a ks-ni2 aq310ain 12.5 preloaded injector.When advancing the plunger, the plunger overrode the lens.The lens rotated to the left and became block/stuck in the injector.Anterior loop was irregular.There was no patient contact.Cause of this incident is unknown.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No patient contact.(b)(4).Evaluation codes: method: device work order search.Results: device work order search: a device work order search was performed and one similar complaint was found.Conclusion: conclusion not yet available.Evaluation is in progress.(b)(4).

Manufacturer Narrative

Conclusion: data analysis performed by staar japan determined that the performance of the preloaded injector system degraded with aging after sterilization and this is more frequent in low diopters (12.5d-16.0d).In addition, the mechanism of the irregularity (lens does not travel as intended) was identified.The key findings was the nature of the lens per different diopter sizes.The low diopter lenses (12.5d-16.0d) contact more on the bottom and ceiling of the cartridge compared to the medium and high diopter lenses.Therefore, it is concluded that the root cause of this nonconformity is the design of the product.(b)(4).

• 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4476768
• MDR Text Key: 16894826
• Report Number: 2023826-2015-00099
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: AQ310AIN
• Other Device ID Number: DIOPTER 12.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1