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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cataract (1766)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - unk a2 - unk, a3 - unk, a4 - unk, a5 - unk, a6 - unk, b3 - unk, d2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry), d4 - unk, d6a - unk, h4 - unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that cataracts was observed in patient.Lens was implanted in 2021.Additional information has been requested but none has been forthcoming.
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -11.0/1.0/075 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od).Lens opacity (cataract) asc was observed on (b)(6) 2023.Lens remains implanted.Reportedly, patient is trailing a scl for the refractive shift and will refer cataract surgery for now.
Additional Manufacturer Narrative
H6: work order search: no similar complaint type events were reported for units within the same lot.Correction: g2: reported as foreign - correct to remove foreign.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17595282
• Report Number: 2023826-2023-03530
• Device Sequence Number: 12617465
• Product Code: QCB
• UDI-Device Identifier: 00841542109154
• UDI-Public: 00841542109154
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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: Required Intervention
• Patient Sex: Female