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

Model Number VICM512.6

Device Problems Misfocusing (1401); Improper or Incorrect Procedure or Method (2017)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140)

Event Date 01/09/2023

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of a diopter of -9.0 was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2023, the lens was removed and replaced for a different model due to refractive surprise and blurred vison.Cause of the event is unknown.Reportedly, "surgical incision induced more astimatism than expected," and "refractive miss - patient had 1.D of astigmastism after spherical icl placement, despite having only 0.5d pre-op so i exchanged the spherical icl for a toric." the status of the eye is reported as, "heathy.".

Manufacturer Narrative

Weight-race:unk.Work order search found no similar complaints.Claim# (b)(4).

Manufacturer Narrative

Corrected data: d9- returned to manufacturer: "13-mar-2023" should be corrected to "10-mar-2023." b5- "cause is unknown and the device failed to perform as intended." device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Claim# (b)(4).

Manufacturer Narrative

Additional data: h3- device evaluation: dimensional and functional inspection found the lens to be within specifications.Corrected data: b5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -9.00d into the patients left eye (os) on (b)(6) 2022.The patient experienced refractive surprise and blurred vision.Reportedly "1d astigmatism after spherical icl placement, despite having only 0.50d pre-op".On (b)(6) 2023 the lens was exchanged for the different model/ same length and the problem was resolved.Status of the eye is noted as "healthy".The cause for this event was unknown and the device failed to perform as intended.- "surgical incision induced more astigmatism than expected".H6- medical device problem code: "2017" should be removed.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16595254
• MDR Text Key: 311822505
• Report Number: 2023826-2023-00997
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119160
• UDI-Public: 00841542119160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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
• Treatment: CARTRIDGE MODEL: SFC-45 - LOT# 1585270; FOAM TIP PLUNGER - LOT# 1581847; INJECTOR MODEL: MSI-PF - LOT# 1546197
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female