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

Model Number	TMICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6, -11.50/2.0/095 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2020.The lens was explanted and the lens was replaced in a second surgery with a shorter length lens due to excessive vault on (b)(6) 2021.This resolved the problem.Cause of the event is reported as patient related factor and device.Reportedly, "wtw measurement called for 12.6mm lens(staar optimized).Unclear if there was a an abnormal sulcus anatomy causing excess vault.Per reporter, "vault is now excellent, patient notices significantly reduced glare.".

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11238074
• Report Number: 2023826-2021-00173
• Device Sequence Number: 19864963
• Product Code: QCB
• UDI-Device Identifier: 00841542107075
• UDI-Public: 00841542107075
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/27/2021
• 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#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-TF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR