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

Model Number MICL13.2

Device Problems Misfocusing (1401); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Decompensation (1790); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Pt info: unk.Date of event - unk.Device manufacture date - unk claim# (b)(4).

Event Description

The reporter states an implantable collamer lens was implanted into the patient's left (os) eye.The surgeon reports high vault, elevated iop, and pressure-lowering medication administered.

Manufacturer Narrative

A 13.2mm micl13.2 icl was implanted into the patient's eye on (b)(6) 2021.On (b)(6) 2021 the lens was exchanged with a shorter lens.The problem was not resolved.See mfr rep# 2023826-2021-03007, for exchanged lens.The surgeon reports additional symptoms: angle closure, refractive surprise, significant reduction of irido-corneal angles (ica), pupil block, corneal decompensation, blurred vision, enlargement of pi, addition of pi-yag.The cause is related as patient-related: "lens too long for patient's wtw." h6-health effect clinical code 4581 (angle closure, significant reduction of ica).Device code 1494 (acd<3.0mm).Claim# (b)(4).

Manufacturer Narrative

Additional information: h3 - device evaluation: lens was returned in specimen cup, dry, with residue/debris on product.Visual inspection found debris throughout the lens and residue on the haptic.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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 ; 8002927902
• MDR Report Key: 12148265
• MDR Text Key: 260979947
• Report Number: 2023826-2021-02424
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

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 Expiration Date: 01/31/2023
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/11/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 11/17/2021
• Supplement Dates FDA Received: 07/31/2021; 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2021
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 23 YR
• Patient Sex: Female