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

Model Number	MICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is not marketed in the u.S.(b)(4).Claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6, -13.0 diopter, implantable collamer lens into the patient's left eye (os) on (b)(6) 2020.The lens tore during injection.There was patient contact (lens touched the eye) with no patient injury.The lens was implanted, removed, and replaced intraoperatively.This resolved the problem.Cause of the event is reported as device.Reportedly, "root cause is that the plunger did not push the whole lens forward but allowed one footplate to get caught on the side of the plunger.That is where the piece was found.".
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: lens was returned in micro-centrifuge vial, in liquid.Visual inspection found haptic torn.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - "the lens was implanted, removed and replaced inraoperatively" should be corrected to "the lens was implanted and removed intraoperatively and later the same day replaced the same day".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: 10786737
• Report Number: 2023826-2020-02504
• Device Sequence Number: 16871034
• Product Code: MTA
• UDI-Device Identifier: 00841542103084
• UDI-Public: 00841542103084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2020

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: 10/31/2021
• Device Model Number: MICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 05/07/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/27/2021; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR