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

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Pt information: unk.Event date: unk.Expiration date - unk.Implant and/or explant dates: na.Initial reporter: unk.Device evaluated by manufacturer? no.Product not returned.Mfg date: unk.(b)(4).Product not returned.

Event Description

The reporter indicated an aa4203tl silicone single piece lens, 21.0 se/2.0 diopter, became jammed in the injector.There was no patient contact.The reporter indicated there was an injector problem.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

The product for this complaint was not returned for evaluation, however, the lens was returned.Visual inspection of the lens found pieces of the lens optic and one haptic torn off and missing.The lens was returned dry and there was evidence of clear surgical residue.The cartridge was not returned.(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: 5898596
• MDR Text Key: 52840455
• Report Number: 2023826-2016-01156
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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