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

Model Number VTICM5_13.2

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

Patient Problems Inflammation (1932); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.B3: unk.D6b: unk.H6: health impact- clinical code: 4581 - iris rubbing; ache.H6: health effect impact code: 4644 - steroids.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -09.00/+1.5/105 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2023.Shallow anterior chamber (ac) and excessive vaulting was noted.There was pigment on icl from pupil margin, so there may be iris rubbing.The patient complained of ache from time to time.The lens remained implanted.A course of steroids was administered.Post-op, the patients ocular discomfort has mostly subsided already.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Corrected data: h6-health effect- impact code: "4627" should be removed and "4629" should be added.Claim# (b)(4).

Manufacturer Narrative

Corrected data/ additional data: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.0/+1.5/105 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced excessive vault, shallow ac,inflammation, iris chafing,pigment on icl, and medication was prescribed.Reportedly "vision is great and refractive outcome is very good.However, her ac in both eyes is quite shallow.Vault is high (approx 1500-2000 micron)" and "i have started a course of steroids to counter any mild underlying inflammation".It was reported that "the patient has had re exchange for a different lens" and "this was not straight forward and the patient had quite a bit of post-op difficulties but these seem to have settled now".H6: health impact code: "4627" should be added.H6: health effect- clinical code: "4581- shallow ac, iris chafing.Pigment on icl" and "1932" should be added.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: 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: 17715559
• MDR Text Key: 323037443
• Report Number: 2023826-2023-03872
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2023

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
• Device Operator: Health Professional
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 01/22/2024; 01/25/2024
• Supplement Dates FDA Received: 01/24/2024; 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2023
• 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 SFC45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female