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

Catalog Number N/A

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2023

Event Type  Injury  

Event Description

The reporter indicated that an implantable collamer lens of unknown model and size was implanted.Doctor requested consultation for patient with icl rotation and pigment dispersion.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

4581-pigment dispersion claim#: (b)(4).

Manufacturer Narrative

Corrected data: b5-the reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -9.00/1.0/154 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6)2023.Excessive vault; lens rotation; pigment dispersion; blurred vision and unreactive (fixed) pupil was reported.On 02-oct-2023 the lens was repositioned and this did not resolve the problem.Anterior chamber irrigation/evacuation of visco/fluids was performed.Patient is on ophthalmic medications.(b)(6)-pigment dispersion; unreactive(fixed) pipil.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -9.00/1.0/154 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.Excessive vault; lens rotation; pigment dispersion; blurred vision and unreactive (fixed) pupil was reported.On (b)(6) 2023 the lens was repositioned and this did not resolve the problem.Anterior chamber irrigation/evacuation of visco/fluids was performed.Patient is on ophthalmic medications.

• 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
• MDR Report Key: 18060314
• MDR Text Key: 327264157
• Report Number: 2023826-2023-04944
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/20/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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 (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female