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

Model Number	TMICL13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Race: unk.Ethnicity: unk.Claim # (b)(6).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -14.00/+1.0/074 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to patient experienced a refractive surprise (va was 20/400) and blurred vision.The lens was replaced with another same model/length but different diopter lens and the problem was resolved.The patient is doing well.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned in liquid, in a vial.Visual inspection found one haptic torn.Claim # (b)(4).
Additional Manufacturer Narrative
H3) device evaluation: the lens was returned in liquid in a vial.Visual inspection found haptic torn to the lens.Dimensional and functional inspection found the lens to be within specifications.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 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13286530
• Report Number: 2023826-2022-00179
• Device Sequence Number: 17220307
• Product Code: QCB
• UDI-Device Identifier: 00841542109574
• UDI-Public: 00841542109574
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2021

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: 01/31/2023
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/24/2022; 06/28/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/17/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female