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

Model Number	S1514441
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter (consumer) indicated that a 13.2mm vicm5_13.2 -11.50 diopter implantable collamer lens was implanted into the patients left eye (os) on 29-jun-2022.Reporter (consumer) experienced halos, he states " its really bad at night".Lens remains implanted.Reporter stated " right now they gave me glaucoma drops and that seems to help".If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: it was later reported that the patient had an appointment on (b)(6) 2023.The reporter stated " 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".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 91016
• MDR Report Key: 16748170
• Report Number: 2023826-2023-01388
• Device Sequence Number: 20976443
• Product Code: MTA
• UDI-Device Identifier: 00841542119443
• UDI-Public: 00841542119443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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
• Report Date (Section B): 03/16/2023

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: 04/30/2024
• Device Model Number: S1514441
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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