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 Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted 13.2mm tmicl13.2 implantable collamer lens, -14.0/+4.0/093 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2020.The surgeon reports excessive vault and elevated iop, which responded to enhanced pis.Reportedly, the lens remains implanted.
Additional Manufacturer Narrative
B5-updated info: unreactive (fixed) pupil and addition of new pi-yag also reported.On (b)(6) 2020, the lens was explanted.After explant the eye status is listed as deepened ac, good iop, pupil still sluggish at 5.5mm.The cause of the event is reported as device: sulcus diameter in vivo appears much smaller than the nomogram-recommended 13.2mm ticl.H6-clinical code 4581: [unreactive (fixed) pupil, deepened ac].Claim# (b)(4).
Additional Manufacturer Narrative
H3- device evaluation: lens was returned dry in a contact lens case.Visual inspection found the haptic torn.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
• MDR Report Key: 11135881
• Report Number: 2023826-2021-00039
• Device Sequence Number: 19844157
• Product Code: QCB
• UDI-Device Identifier: 00841542109635
• UDI-Public: 00841542109635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

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: 11/30/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 03/02/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/02/2021; 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR