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	Headache (1880); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Eye Pain (4467)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -15.00/1.5/78 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.The patient experienced pain, headache, light sensitivity, and blurry vision.Pupil block with elevated iop was observed.Additional surgical intervention (yag pi) and medical intervention (tropicamide, phenylephrine, cosopt pf, diamox, brominidine) were performed/prescribed.It was reported that the problem resolved, status of eye "normal".In the reporters opinion the cause of this event was the device.
Additional Manufacturer Narrative
B3 - (b)(6) 2020.B5 - evaluation on 19-dec-2020: examination demonstrated corneal edema, a mid-dilated pupil, elevated iop, elevated icl vault and iop.Yag performed.Aqueous tap done (b)(6) 2020.(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 ; 8002927902
• MDR Report Key: 11200458
• Report Number: 2023826-2021-00183
• Device Sequence Number: 2270492
• Product Code: QCB
• UDI-Device Identifier: 00841542109727
• UDI-Public: 00841542109727
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 08/31/2022
• Device Model Number: TMICL13.2
• 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: 12/21/2020
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female