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

Model Number	TMICL13.7
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim # (b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, tmicl13.7, -15.5/3.5/105 (sphere/cylinder/axis), implantable collamer lens, was implanted into the patients right eye (od) on (b)(6) 2020.On (b)(6) 2021 the lens was exchanged for a different model and power lens due to glare/haloes.This exchange did not resolve the problem.The reporter stated "glare/aberations improved but still present.Plan on doing lasik for residual refractive error." in the reporters opinion " device and patient-related factor" was the cause of this event.For cause details the reporter stated " device causes mild aberations- pt very sensitive to aberations".

• 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: 12725161
• Report Number: 2023826-2021-04177
• Device Sequence Number: 4282085
• Product Code: QCB
• UDI-Device Identifier: 00841542112000
• UDI-Public: 00841542112000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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: 01/31/2022
• Device Model Number: TMICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/30/2021
• 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: 32 YR