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

Model Number MICL12.6

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter states a 12.6mm micl12.6 implantable collamer lens -11.0 diopter was implanted into the patient's eye upside down on (b)(6) 2021.On (b)(6) 2021 the lens was explanted and replaced with a back-up lens.No patient injury is reported.

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid in a vial with residue on the lens surface.Visual inspection found residue on the lens surface and that the haptic and optic were torn.Claim# (b)(4).

Manufacturer Narrative

B5-lens implanted into the patient's right (od) eye.The cause is reported as user error.The lens was repositioned on (b)(6) 2021 and was then explanted and replaced.The problem was resolved.Claim#: (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
• MDR Report Key: 11894541
• MDR Text Key: 252954735
• Report Number: 2023826-2021-01708
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 07/01/2021
• Supplement Dates FDA Received: 06/25/2021; 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL-LIOLI-24, LOT#-UNK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR