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

Model Number VICM5_13.2

Device Problem Optical Problem (3001)

Patient Problem Halo (2227)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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).

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).

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)
• Type of Device: 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
• MDR Text Key: 308230972
• Report Number: 2023826-2022-04797
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119450
• UDI-Public: 00841542119450
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 04/04/2023; 04/12/2023; 04/27/2023
• Supplement Dates FDA Received: 04/04/2023; 04/17/2023; 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention