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

Model Number VICM5_12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Decompensation (1790); Glaucoma (1875); Intraocular Pressure Increased (1937); Pain (1994); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2022

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6; -2 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2022.The patient experienced excessive vaulting; pupil block; angle closure with elevated intraocular pressure; corneal decompensation; medication used; pain; glaucoma and it was noted that yag surgery was performed as well as paracentesis.On (b)(6) 2022 the lens was explanted.Post op results reported the problem was resolved and with the lens removed the patient now has corneal edema; mid dilated pupil; iris trauma.The cause of the event was reported as the device and noted "icl seems to big for this eye despite correct measurement and calculation preoperatively".

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim# (b)(4).

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial in liquid, with residue/debris on the lens.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens within specifications.Claim#: (b)(4).

Manufacturer Narrative

Additional information: b5 - it was later reported corrected va is 6/6 with some degree with iris atrophy.H6 - health effect clinical code: 4581- iris atrophy.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13529754
• MDR Text Key: 285810572
• Report Number: 2023826-2022-00498
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: VICM5_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
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 05/18/2022
• Supplement Dates FDA Received: 04/13/2022; 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female