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

Model Number	VTICMO12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient info: unk.Date of event: unk.Health impact- clinical code: 4581 - significant reduction of irido-corneal angles health impact - additional surgery: 4625 - addition new pi.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -17.00/+2.5/095 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2022.The lens was removed on (b)(6) 2023 due to excessive vaulting and significant reduction of irido-corneal angles.Additional surgery was performed with the addition of new pi.The lens was replaced with a shorter lens and the problem was resolved.There was a small central abrasion but it was not caused by the icl.The cause of the event was unknown.
Additional Manufacturer Narrative
Corrected data: b5- the surgeon implanted a 12.6 vticmo 12.6 implantable collamer lens of diopter -17.00/+2.50/095 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The patient experienced an excessive vault, significant reduction of iridocorneal angles, and yag was performed.On (b)(6) 2023 the lens was explanted.On the same day separate surgery a replacement lens of a shorter length lens was implanted and the problem was resolved.Status of the eye states, "clear, quiet, small central abrasion".Reportedly " the corneal abrasion was not related to the icl".Additional information states, "m -3.50ou 20/80+ (expected) was 20/70 pre-op".The cause of the event is unknown and the device did not fail to perform as intended.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16603909
• Report Number: 2023826-2023-00974
• Device Sequence Number: 12310381
• Product Code: QCB
• UDI-Device Identifier: 00841542120678
• UDI-Public: 00841542120678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/24/2023

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: 04/30/2024
• Device Model Number: VTICMO12.6
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male