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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Type of investigation :lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2; -8.00/+1.00/072 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.There was report of pupil block and elevated intraocular pressure; on (b)(6) 2022 it was also noted patient experienced mid dilated pupil; uncorrected visual acuity; corneal edema and a yag pi surgery was performed which relieved the pressure and when the patient returned (b)(6) 2022 they had improved visual acuity/reduced intraocular pressure and mid-dilated pupil.The problem was marked as resolved but noted patient is scheduled to come in for a 1 month follow up.
Additional Manufacturer Narrative
B5 - it was later clarified that "examination on (b)(6) 2022- demonstrated reduced uncorrected visual acuity of 20/32; mild corneal edema; a mid-dilated pupil and non-patent peripheral iridotomy od.Repeat laser iridotomy od immediately relieved the pressure; and the subject returned the following day (b)(6) 2022, with improved visual acuity; reduced intraocular pressure and persistent mid-dilated pupil." the problem was resolved.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: 13546404
• Report Number: 2023826-2022-00529
• Device Sequence Number: 5200275
• Product Code: QCB
• UDI-Device Identifier: 00841542108737
• UDI-Public: 00841542108737
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 07/31/2023
• Device Model Number: TMICL13.2
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: 35 YR
• Patient Sex: Female