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

Model Number MICL 13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026); No Apparent Adverse Event (3189)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted upside down a 13.2mm micl13.2, -12.0 diopter, implantable collamer lens, into the patient's left eye (os) on (b)(6) 2021.There was patient contact (lens touched the eye) with no patient injury.The lens was implanted, removed, and replaced intraoperatively on (b)(6) 2021 with a back-up lens.The problem was resolved.Cause of the event is reported as user error.Reportedly, "initial lens flipped upside down upon insertion into eye.Necessary to remove from eye and at that point, a tear was noted on plate of haptic.".

Manufacturer Narrative

Additional information: h3 device evaluation: lens was returned in micro-centrifuge vial, in liquid.Visual inspection found haptic torn.(b)(4).

Manufacturer Narrative

Corrected data: b5- the reporter indicated that a 13.2mm micl 13.2 of -12.0 diopter implantable collamer lens was implanted into the patients left eye (os) upside down on (b)(6) 2021.Reporter states that the lens was removed intraoperatively from the eye and at that point a tear was noticed on the haptic plate.A backup lens was used and the patient is very happy with the outcome.Claim# (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
• MDR Report Key: 11343191
• MDR Text Key: 232386009
• Report Number: 2023826-2021-00405
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• 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: 01/27/2021

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 10/05/2021
• Supplement Dates FDA Received: 03/18/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45, LOT#1502316.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#1401906.; CARTRIDGE MODEL#SFC-45, LOT#1502316; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK; INJECTOR MODEL#MSI-PF, LOT#1401906
• Patient Age: 24 YR