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

Model Number VICM5 12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5 -6.00d implantable collamer lens (icl) into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral (ou) implantation of icls same day.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.Day 1 visual acuity was noted to be 20/15.Reportedly, the patient presented with fibrin and cell without hypopyon, and was prescribed increased topical steroids with no oral steroids.Left eye (os) was reported to be clear.At one week, visual acuity and status of both eyes (ou) were reported to be 20/12.5 (1.5) with no cell/fibrin.To the best of our knowledge the lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

A4-a6: unk.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacture narrative: a review of the device labeling was completed.Inflammation not limited to: iritis (iridocyclitis), fibrin precipitation, and cells in the anterior chamber are identified in the labeling as a known potential adverse event following icl implantation.The dfu provides the surgeon instruction for lens implantation and complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe and require extended steroid treatment.Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event.Mechanical insult to the iris can result in a prolonged or stronger inflammatory response.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19122111
• MDR Text Key: 340338600
• Report Number: 2023826-2024-01744
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: 00840311300525
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• 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 - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female