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

Model Number	VTICM5 13.2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2 vticm5 13.2 implantable collamer lens of -11.00/1.50/089 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2024.Excessive vault with elevated iop and significant reduction of iridocorneal angles has been reported.The lens currently remains implanted.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b1-adverse event b2-required intervention to prevent permanent impairment/damage (devices) b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault and elevated iop.In a separate visit the lens was exchanged for a shorter length lens and the problem was resolved.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.D6b- (b)(6) 2024 corrected data: d4- model# is vticm5 13.2 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19524841
• Report Number: 2023826-2024-02516
• Device Sequence Number: 18245743
• Product Code: QCB
• UDI-Device Identifier: 00840311311484
• UDI-Public: 00840311311484
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTICM5 13.2
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 27 YR
• Patient Sex: Female