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

Model Number	VICM5_13.2
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter (consumer) indicated that an evo icl was implanted into the patients eye and "halos are so bad at night."no further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b5- the consumer indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -12.00 into the patient's right eye (od) on (b)(6) 2022.The patient experienced haloes and medication was prescribed.Reportedly "i have the evo icl but the halos are so bad at night would a replacement with an evo + icl have better results and help with reducing halos." it was also reported "they gave me glaucoma drops and that seems to help".The lens remains implanted.Claim# (b)(4).
Additional Manufacturer Narrative
Addiitonal data: b5- "the consumer indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -12.00 into the patient's right eye (od) on (b)(6) 2022.The patient experienced haloes.Reportedly "i have the evo icl but the halos are so bad at night would a replacement with an evo + icl have better results and help with reducing halos." the lens remains implanted." h6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the consumer indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -12.00 into the patient's right eye (od) on (b)(6) 2022.The patient experienced haloes and medication was prescribed.Reportedly "i have the evo icl but the halos are so bad at night would a replacement with an evo + icl have better results and help with reducing halos." it was also reported "they gave me glaucoma drops and that seems to help".It was later reported " i had an appointment today and they said the lens' look good and i could get another opinion from one of the surgeons but they suggested that i keep the lens' as is and use glaucoma drops to shrink my pupil to help get rid of the halos." the lens remains implanted.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16080994
• Report Number: 2023826-2022-04797
• Device Sequence Number: 12285188
• Product Code: MTA
• UDI-Device Identifier: 00841542119450
• UDI-Public: 00841542119450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2022

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 Expiration Date: 04/30/2024
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 04/04/2023; 04/12/2023; 04/27/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 04/04/2023; 04/17/2023; 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown