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

Model Number MSI-TR

Device Problems Difficult or Delayed Positioning (1157); Device Operational Issue (2914); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer? no - 81 (other): the product for this complaint was not returned.However the lens and cartridge were returned.(b)(4).

Event Description

The reporter stated an aa4203tl silicone single piece lens 19.0 se/2.0 diopter, tore during the loading process.The reporter indicated the injector was stiff and hard to push and was the cause of the event.There was no patient contact with the lens.

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer? no.Visual inspection of the lens found pieces of lens optic and one haptic torn off and missing.The lens was returned dry and there was evidence of clear surgical residue.Visual inspection of the cartridge found no visible damage.(b)(4).Device not returned.

• 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5926658
• MDR Text Key: 53907066
• Report Number: 2023826-2016-01214
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-TR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL - MTC60- LOT NUMBER UNK; LENS MODEL AA4203TL-SERIAL # (B)(4)
• Patient Age: 71 YR