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	Cataract (1766); 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, -7.50/1.5/086 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) 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
Corrected data: b4- "16-jan-2020" should be corrected to "15-jan-2020" in the initial mdr.G4- "16-jan-2020" should be corrected to "15-jan-2020" in the initial mdr.Additional information: b5- "on (b)(6) 2020 the lens was explanted with a plan for exchange.However, the patient developed an intraoperative cataract during explantation and the decision was made to abort implantation of replacement icl." h6- patient code 3191: secondary surgical intervention; lens explant.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6: patient code 1766 should be in the previous mdr.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5- "on (b)(6) 2020 an icl implantation in the right eye with a larger lens was performed." 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
• MDR Report Key: 9689304
• Report Number: 2023826-2020-00184
• Device Sequence Number: 3474791
• Product Code: QCB
• UDI-Device Identifier: 00841542108676
• UDI-Public: 00841542108676
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 02/28/2020; 05/26/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/24/2020; 04/23/2020; 06/25/2020
• 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