MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number MICL13.2

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Lens not returned.(b)(4).

Event Description

The reporter stated the surgeon had problems folding a 13.2mm micl13.2 implantable collamer lens, -11.0 diopter, and there was no patient contact.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Based on the complaint history, work order search and product evaluation, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5983980
• MDR Text Key: 55833858
• Report Number: 2023826-2016-01328
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103312
• UDI-Public: (01)00841542103312(17)161130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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