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

Model Number	TMICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that as the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -10.0/+2.5/110 (sphere/cylinder/axis) into the patient's eye, it flipped upside down.This occurred on (b)(6) 2020.Reportedly, the lens was then removed and no patient injury occurred.Attempts to obtain additional elevation have not been successful.
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid, in a vial.There was residue on the lens surface.Visual inspection found no visible damage to the lens.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10353754
• Report Number: 2023826-2020-01632
• Device Sequence Number: 16752402
• Product Code: QCB
• UDI-Device Identifier: 00841542106870
• UDI-Public: 00841542106870
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention