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

Model Number	TMICL12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk, ethnicity: unk, race: unk.Explant date: na.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -13.00/+3.5/094 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2020.The lens was reported as having rotated on (b)(6) 2020 and was re-positioned on (b)(6) 2020.The re-positioning resolved the problem.The patient is happy and doing well since toric icl rotation.The lens remained implanted.This was the replacement lens for mfr.Report # 2023826-2020-02281.

• 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: 12030069
• Report Number: 2023826-2021-02011
• Device Sequence Number: 4268796
• Product Code: QCB
• UDI-Device Identifier: 00841542107310
• UDI-Public: 00841542107310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 06/30/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 06/19/2021
• 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
• Patient Age: 27 YR