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

Model Number	TMICL12.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl_12.6; -10.50/+1.00/088 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2021.The patient experienced pupil block with elevated intraocular pressure; acute angle closure secondary to pupillary block following pharmacologic mydriasis; pain; decreased visual acuity; nausea; pupil dilation.It was reported that "subject treated with oral acetazolamide and topical timolol; pilocarpine; latanoprost and brinzolamide over the course of approximately 2 hours.Subject discharged with instructions to use timolol; brimonidine; latanoprost and acetazolamide at home and return for follow-up exam the next day".Post op notes indicated that "the subject returned feeling much better; without pain or headache.Intraocular pressure measured 8 mmhg; and the cornea was clear os.Uncorrected visual acuity improved to 20/16 os.Brimonidine was tapered; and all other medications discontinued".The problem was resolved.The cause of the event was noted as the device.
Additional Manufacturer Narrative
(b)(4).Claim#: (b)(4).
Additional Manufacturer Narrative
B5: "on (b)(6) 2022 lens opacity (cataract) adc was observed.Anterior subcapsular opacity noted as grade1/mild.No action taken, patient remains on study." should be added to the initial mdr.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: 13240884
• Report Number: 2023826-2022-00156
• Device Sequence Number: 19979668
• Product Code: QCB
• UDI-Device Identifier: 00841542106917
• UDI-Public: 00841542106917
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 03/31/2023
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2021
• 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
• Patient Age: 39 YR
• Patient Sex: Female