MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR INJECTOR; INTRAOCULAR LENS GUIDE

Model Number MSI-TM

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(expiration date): unk, no lot number reported.(device manufacturing date): unk, no lot number reported.Please refer to mdr # 2023826-2019-00501 for lens details.Claim# (b)(4).

Event Description

The reporter stated "lens was loaded into the cq cartridge, leading haptic was bend over.It appears the msi-tm injector rod was bent in the upward position.We did not have the lot number for the injector and the injector was trashed.We got another injector, another cq cartridge and another cq iol and successfully implanted into the eye".

• Brand Name: MICROSTAAR INJECTOR
• Type of Device: INTRAOCULAR LENS GUIDE
• 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: 8465490
• MDR Text Key: 140501676
• Report Number: 2023826-2019-00518
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSI-TM
• 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: 02/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 86 YR