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

Model Number MICL13.2

Device Problems Device Issue (2379); No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Lens was returned dry, in a ziploc bag.Visual inspection found residue on the lens surface and portion of the lens missing.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon was not happy with the way a 13.2mm micl13.2, -8.5 diopter, implantable collamer lens folded at loading.There was no patient contact and the backup lens was used.

Manufacturer Narrative

Corrected data: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7627372
• MDR Text Key: 111999663
• Report Number: 2023826-2018-00927
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103268
• UDI-Public: 00841542103268
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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 Expiration Date: 11/30/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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
• Patient Age: 22 YR