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

Model Number MICL13.2

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

Lens was returned in liquid in the lens vial.Visual inspection found a tear in the haptic.No similar complaint type events reported for units within the same lot.(b)(4).

Event Description

Reportedly, while preparing to insert a 13.2mm micl13.2, diopter -10.0 implantable collamer lens into the patient's left (os) eye, the lens was damaged.The returned box states the lens was not implanted and "lens removed-was not opening properly." the surgery date is listed as (b)(6) 2017.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

Additional information: surgeon states that when the lens was injected into the eye it did not unfold properly.The lens was in the eye still folded "despite waiting for some time." the lens was implanted, removed, and "ultimately a back-up lens was implanted afterward." (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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 ; 8002927902
• MDR Report Key: 7006984
• MDR Text Key: 92053517
• Report Number: 2023826-2017-01692
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 26 YR