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

Model Number KS-NI2 AQ310AIN

Device Problem Misfocusing (1401)

Patient Problem Blurred Vision (2137)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Age: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Implanted: unk.Work order search: no similar complaint type events were reported for units within the same lot.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order (s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contribute to the complaint issue.(b)(4).

Event Description

The reporter indicated that four days after implanting a ks-ni2 aq310ain, 25.0 diopter, intraocular lens into the patients left eye (os) refractive surprise was observed.The patient has been monitored for about a month, but the situation has not changed, eyesight is about 20/29.Lens remains implanted and it was reported that there is no plan to exchange the lens but monitor the patient.

• 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
• MDR Report Key: 9156918
• MDR Text Key: 162634160
• Report Number: 2023826-2019-01865
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: KS-NI2 AQ310AIN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2018
• 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