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

Model Number	VICM5_13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: 4581 - hyperopia.Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -4.5 diopter implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The surgeon reports that the patient had a slight increase in vault over a few days and hyperopia.The lens was repositioned in the vertical position; from 30 degrees to 90 and vault is at 480um.Lens remains implanted.
Additional Manufacturer Narrative
Additional data: h6: health effect- clinical code: 4581- significant reduction of iridocorneal angles.H6: health effect- clinical code: 4581- photophobia.B5: the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter +4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault, hyperopia, glares/haloes, significant reduction of iridocorneal angles and photophobia.On (b)(6) 2023 the lens was repositioned vertically.Reportedly "icl still tilted.Still very much bothered by photophobia".The problem was not resolved.Status of the eye: "severe photophobia, slightly tilted icl".The cause of the event was the device.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -4.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault, hyperopia, glares/haloes, significant reduction of iridocorneal angles and photophobia.On (b)(6) 2023 the lens was repositioned vertically.Reportedly "icl still tilted.Still very much bothered by photophobia".The lens remains implanted and the problem was not resolved.Status of the eye: "severe photophobia, slightly tilted icl".The cause of the event was the device.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: josolene enriquez ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 16802019
• Report Number: 2023826-2023-01489
• Device Sequence Number: 7131984
• Product Code: MTA
• UDI-Device Identifier: 00840311300822
• UDI-Public: 00840311300822
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2023

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: 12/31/2025
• Device Model Number: VICM5_13.2
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 07/18/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/30/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2023
• 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: 51 YR
• Patient Sex: Male