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

Model Number	MICL 13.2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.".
Additional Manufacturer Narrative
Additional information: h3 device evaluation: lens was returned in micro-centrifuge vial, in liquid.Visual inspection found haptic torn.(b)(4).
Additional 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)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11343191
• Report Number: 2023826-2021-00405
• Device Sequence Number: 4959600
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/01/2021; 10/05/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/18/2021; 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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