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

Model Number MICL 13.7

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Glaucoma (1875); Intraocular Pressure Increased (1937); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

A4 - unk.A5 - unk.A6 - unk.B3 - unk.D2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry).D4 - unk.H4 - unk.H6- health effect impact code 4581: pigment dispersion, iris atrophy.Claim#(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.7mm micl13.7, implantable collamer lens into the patient's left eye (os) on (b)(6)2017.The lens was explanted due to permanent loss of bcva, elevated iop 38mmhg without pupil block and angle closure(assesed on (b)(6)2023), pigment dispersion, blurred vision, iris atrophy, and excessive vault on (b)(6)2023.Addition of new pi, yag, performed on (b)(6)2017.This did not resolved the problem.Cause of the event is reported as device.Lens possibly too large.Iridotomy was not done per charge review.Lpi done 9 months post-op.

Manufacturer Narrative

Corrected data: b5- the reporter indicated the surgeon implanted an 13.7mm micl 13.7 implantable collamer lens into the patient's left eye (os) on (b)(6) 2017.The patient experienced glaucoma, excessive vault, permanent loss of bcva, elevated iop, pigment dispersion, blurred vision, iris atrophy, zonular laxity, significant reduction of iridocorneal angles, yag was performed, and medication was prescribed.On (b)(6) 2023 the lens was explanted but the problem was not resolved.Status of eye: "some zonular laxity noted at surgery.Has glaucomatous optic neuropathy with iop controlled on timilol." additional information provided: "icl saved for analysis by staar and confirmation of size/power.Rt visian icl subsequently removed and kdb goniotomy performed on (b)(6) 2023".The reporter indicated the cause of the event was the device.Cause details provided: " lens possibly too large, w excessive vault, pigment dispersion.Preop iridoctomy was not done per chart review.Had lpi done 9 months post op".H6- health effect- clinical code: 4581- "significant reduction of iridocorneal angles" and "zonular laxity" should be added.H6- health effect- clinical code: "1875" should be added.H6-health effect- impact code: "4644" should be added.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
• MDR Report Key: 17119687
• MDR Text Key: 317129036
• Report Number: 2023826-2023-02156
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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: MICL 13.7
• 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: 05/22/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male