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

Model Number	TMICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted upside down a 12.6mm tmicl12.6, -10.50/1.5/078 (sphere/cylinder/axis), implantable collamer lens, into the patient's left eye (os) on (b)(6) 2020.There was patient contact (lens touched the eye) with no patient injury.Blurred vision was observed and lens was repositioned on (b)(6) 2020, this did not resolve the problem.The lens was removed and exchanged on (b)(6) 2020 with a same size, spherical lens.This resolved the problem.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

• 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: 10560526
• Report Number: 2023826-2020-02112
• Device Sequence Number: 2822424
• Product Code: QCB
• UDI-Device Identifier: 00841542106924
• UDI-Public: 00841542106924
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 05/31/2022
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/21/2020
• 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: 22 YR