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

Model Number	TMICL13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight - unk.Ethnicity - unk.Implant date - unk.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 a 13.2mm, tmicl13.2, -5.50/2.5/161 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2020.On (b)(6) 2020 the lens was removed and replaced with a shorter length lens due to refractive surprise, glare/haloes, and blurred vision.This resolved the problem.Cause of the event is reported as user error (user transpose error, plus to minus cylinder resulted in the incorrect data entry.).Reportedly, patient satisfied with vision.

• 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: 10937922
• Report Number: 2023826-2020-02787
• Device Sequence Number: 14249772
• Product Code: QCB
• UDI-Device Identifier: 00841542108416
• UDI-Public: 00841542108416
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 11/30/2020
• Device Model Number: TMICL13.2
• 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: 11/12/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL# SFC-45, LOT#UNK.; FOAMTIPPLUNGER MODEL# FTP, LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR