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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patients right eye (od) in (b)(6) 2022.The patient experienced lens rotation.Reportedly "both her icls have rotated off axis - her right icl rotated almost immediately - but was near max power correction and patient was happy with va.There is also now regression noted as well (very highly myopic pre-op) and the left icl recently rotated too".The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

B5- the reporter indicated that the surgeon implanted a 12.1mm vticmo 12.1 implantable collamer lens of diopter -18.00/1.5/146 (sphere/cylinder/axis) into the patients right eye (od)on july/19/2022.The patient experienced product conformity- "icl rotated off the axis".Reportedly "both her icls have rotated off axis - her right icl rotated almost immediately - but was near max power correction and patient was happy with va.There is also now regression noted as well (very highly myopic pre-op".The lens remains implanted.The reporter indicated the cause of the event was the device and the device failed to perform as intended.Cause details provided: "icl rotation- used recommended sizing from starr calculations".H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19209042
• MDR Text Key: 341366427
• Report Number: 2023826-2024-01994
• 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,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/12/2024
• Date Device Manufactured: 12/15/2021
• 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 (FTP), LOT# UNK; MSI-PF, LOT# UNK
• Patient Age: 40 YR
• Patient Sex: Female