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

Model Number	VTICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Corneal Edema (1791)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -07.50/+2.0/089 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2023.The reporter indicated there was trace corneal edema post-op.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.B3: unk.D6b: na.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
At the last visit on (b)(6) 2023, the sle was all normal.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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17253007
• Report Number: 2023826-2023-02655
• Device Sequence Number: 5296874
• Product Code: QCB
• UDI-Device Identifier: 00841542116244
• UDI-Public: 00841542116244
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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
• Patient Sex: Female