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

Model Number	VICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - 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 indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -13.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.Patients vision after surgery was 20/50 +1 with vault around 1000.After 2 weeks with no visual improvement, the lens was exchanged for a toric lens of shorter length and different power.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5- per updated information the problem resolved.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -13.50 into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault and refractive surprise.Reportedly "no visual improvement" (va 20/50).Higher vaulting was also noted".On (b)(6) 2023 the lens was exchanged with a toric model, shorter length and the problem was resolved.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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17484564
• Report Number: 2023826-2023-03356
• Device Sequence Number: 7383194
• Product Code: MTA
• UDI-Device Identifier: 00841542119252
• UDI-Public: 00841542119252
• 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
• Device Explanted 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,Followup
• Report Date (Section B): 07/12/2023

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: 10/31/2024
• Device Model Number: VICM5_12.6
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 03/26/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/08/2023; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• 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 Sex: Unknown