MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN 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 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated that a micl13.2 implantable collamer lens, -15.0 diopter, would not fold very well in the cartridge during the loading procedure.The lens was not implanted and there was no patient contact.The backup lens was implanted.The reporter stated that cause of the event was unknown.

Manufacturer Narrative

Device evaluation: lens was returned in liquid, in a lens vial.Visual inspection found no visible damage to the lens.Work order search: no similar claims were reported for units within the same lot.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: VISIAN 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: 6277723
• MDR Text Key: 65770271
• Report Number: 2023826-2017-00160
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103398
• UDI-Public: (01)00841542103398(17)180930
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL AND LOT# UNK; INJECTOR MODEL AND LOT# UNK
• Patient Age: 27 YR