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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: (b)(4) - angle closure.Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2; -14.00/1.0/145 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 202.It was reported that the size is too large causing dangerous vault and intermittent angle closure.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5 - it was later reported that on (b)(6) 2022 the lens was explanted and replaced with a shorter length lens.With no patient injury or sutures.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: 13476644
• Report Number: 2023826-2022-00422
• Device Sequence Number: 5349063
• Product Code: QCB
• UDI-Device Identifier: 00841542109574
• UDI-Public: 00841542109574
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL13.2
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown