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

Model Number MSI-TM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated the surgeon inserted an aq2010v silicone three piece lens, +19.0 diopter, on (b)(6) 2016 and the lens was torn by the inserting device.The incision was enlarged to remove the lens.The backup lens was implanted and a suture was required to close the incision.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Device evaluation: visual inspection of the returned product found no visible damage to the injector.There was foreign material in the injector.The cartridge was returned with a damaged tip.The lens was returned and the lens optic was cut into two pieces, with a piece missing.The lens was returned dry.Lens work search: no similar complaints were reported for units within the same lot.Claim # (b)(4).

• 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: 6150079
• MDR Text Key: 61589440
• Report Number: 2023826-2016-01731
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MSI-TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 AND LOT NUMBER UNK; LENS MODEL AQ2010V - SERIAL NUMBER (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR