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	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -7.50/1.5/089 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.Low vault was observed.Lens remains implanted.Cause of the event is reported as unknown.Reportedly, lens exchange to occur.
Additional Manufacturer Narrative
Additional information: b5- "on 26-feb-2020, the surgeon operated on the left eye to perform icl exchange." h6- patient code 3191: lens exchange.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b4- "(b)(6) 2020" should be corrected to "(b)(6) 2020" in the initial mdr.G4-"16-jan-2020" should be corrected to "15-jan-2020" in the initial mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in liquid in a lens vial.Visual inspection found no visible damage to the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b1- adverse event should be marked in mdr supplemental #2.B2- required intervention should be marked in mdr supplemental #2.D7- explant date: (b)(6) 2020 should be in mdr supplemental #2.H1- serious injury should be in mdr supplemental #2.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: 9689269
• Report Number: 2023826-2020-00283
• Device Sequence Number: 11600706
• Product Code: QCB
• UDI-Device Identifier: 00841542108676
• UDI-Public: 00841542108676
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 02/28/2020; 05/05/2020; 10/29/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/24/2020; 04/23/2020; 06/25/2020; 10/30/2020
• 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: 25 YR