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

Model Number	VTICM5_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 -14.00/2.5/072 (sphere/cylinder/axis) was implanted into the patient's left eye (os) 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 shorter length lens of 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
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found haptic torn.Dimensional and functional inspection found the lens to be within specifications.Corrected data: b5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -14.00/2.5/072 (sphere/cylinder/axis) into the patient's left eye (os) 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 shorter lens length and a different power and the problem was resolved.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 17484473
• Report Number: 2023826-2023-03355
• Device Sequence Number: 12577875
• Product Code: QCB
• UDI-Device Identifier: 00841542115551
• UDI-Public: 00841542115551
• 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: 05/31/2025
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; 12/22/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/08/2023; 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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