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

Model Number	TMICL
Medical Device Problem Codes	Misfocusing (1401); Unintended Movement (3026)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm tmicl13.2 -5.5/1.0/066 (sphere/cylinder/axis) implantable collamer lens was implanted upside down into the patient's right eye (od) on (b)(6) 2022.Refractive surprise was reported.On (b)(6) 2022 the lens was explanted.On the same day in a separate surgery a backup lens of different axis was implanted.The exchange resolved the problem.Cause of event is unknown.
Additional Manufacturer Narrative
Lens work order search-no similar complaints reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
B5: per additional information, "undesirable refractive outcome" after the lens was exchanged.Refractive surprise was also reported.Problem was not resolved.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14862676
• Report Number: 2023826-2022-01908
• Device Sequence Number: 4878276
• Product Code: QCB
• UDI-Device Identifier: 00841542108386
• UDI-Public: 00841542108386
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: TMICL
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 11/15/2022
• Date Device Manufactured: 07/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INJECTOR MODEL-LIOLI-24, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female