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

Model Number	TMICL_12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim#: (b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's right eye (od) in dec 2020.The surgeon has reported the patient now has shallow vault and small subcapsular cataracts in the midperipheral zone superiorly.It was also noted the patient is happy visually and refractive has been consistent.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5 - it was later updated that the surgeon anticipates to do an exchange in the future.Postoperative notes indicated "no subject change in vision, small peripheral cataract".H6 - medical device problem code - 1494: off-label use (over 45yrs of age at date of implant).Claim#: (b)(4).
Additional Manufacturer Narrative
Claim#:(b)(4).
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that an implantable collamer lens was implanted into the patient's right eye (od) in (b)(6) 2020.The surgeon has reported the patient had shallow vault and small subcapsular cataracts in the midperipheral zone superiorly.On 29-jun-2022 the lens was exchanged with a longer length/similar power lens.This resolved the problem.The cause of the event was reported as unknown.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13563731
• Report Number: 2023826-2022-00542
• Device Sequence Number: 1764421
• Product Code: QCB
• UDI-Device Identifier: 00841542107419
• UDI-Public: 00841542107419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2022
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: TMICL_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/20/2022; 04/22/2022; 07/06/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/23/2022; 04/22/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male