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

Model Number VTICMO12.6

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

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Pupillary Block (2026); Discomfort (2330)

Event Date 05/30/2023

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -10.00/+1.5/074 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to patient experienced pupil block with elevated intraocular pressure (iop).The lens was replaced with another same model/length lens and the problem was resolved.The cause of the event was the device - the lens had not central hole.

Manufacturer Narrative

A4: unk, a5: unk, a6: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned in a microcentrifuge vial, with moisture on product.Visual inspection found no visible damage to the lens (the perforating hole was not present).Dimensional and refraction (functional) verification was performed and the lens was found to be in specification.H6: device history record (dhr) review: the investigative results determined the milling tool not being replaced after its max life was reached is most likely the root cause to why the central hole was not present on the lens.August 2022, it has been made a common practice across manufacturing to change the primary tool prior to max life being reached to minimize chipped edges/holes.This practice will also help prevent further occurrences of a missing central hole.In addition, retraining for sop & work instruction on detection of missing central hole and/or lens defects have been performed.Specific operators responsible have been made aware.Claim#: (b)(4).

Manufacturer Narrative

Corrected information: b5: the reporter indicated that the surgeon noted a 12.6mm vticmo 12.6 implantable collamer lens of diopter -10.0/+1.5/074 (sphere/cylinder/axis) into the left eye (os) on (b)(6) 2023.Product non-conformity was noted as "the icl lens have no central hole".The patient experienced elevated iop with pupil block, pain and discomfort.Reportedly, "the patient felt pain and uncomfortable".On (b)(6) 2023 the lens was exchanged with the same parameters and the problem was resolved.Status of the eye: "the patient has just completed the surgery and is still in follow-up.The patient's eye condition is good".The reporter indicated the cause of the event was the device.Cause details provided: "the icl lens have no central hole".H6: health effect- clinical code: "2330" and "1994" 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: 17200420
• MDR Text Key: 317851333
• Report Number: 2023826-2023-02472
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2023

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: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 11/28/2023
• Supplement Dates FDA Received: 08/16/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2022
• 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.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female