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

Model Number	TMICL12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494)
Health Effect - Clinical Codes	Pupillary Block (2026); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that 12.6mm tmicl12.6; -7.00/+3.50/105 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2021; as a replacement lens.It was noted the patient experienced pupil block on the replacement lens which was caused from the initial implanted lenses angle closure.The patient then felt vision wasn't good and still had a block pupil with residual rx right eye -0.25; +1.25; 145.The surgeon decided to perform prk surgery.It was indicated the patient's vision is still blurry.See mdr# 2023826-2022-00174 for initial implant.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
Claim#: (b)(4).
Event or Problem Description
The reporter indicated that 12.6mm tmicl12.6; -7.00/+3.50/105 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2021; as a replacement lens.It was noted the patient experienced pupil block on the replacement lens which was caused from the initial implanted lenses angle closure.The patient then felt vision wasn't good and still had a block pupil with residual rx right eye -0.25; +1.25; 145.The surgeon decided to perform prk surgery.It was indicated the patient's vision is still blurry.See mdr# 2023826-2022-00174 for initial implant.If additional information is received a supplemental medwatch report will be submitted.

• 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: 13311393
• Report Number: 2023826-2022-00176
• Device Sequence Number: 14685955
• Product Code: QCB
• UDI-Device Identifier: 00841542106474
• UDI-Public: 00841542106474
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 10/31/2023
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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 Sex: Female