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

Model Number	TMICL12.1
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
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 a 12.1 mm, ticml12.1, 14.00/3.0/086, implantable collamer lens, into the patient's right eye (od).Accommodative spasms, refractive change overtime, and foggy vision was observed.Lens remains implanted.Cause of the event is reported as unknown.Reportedly, "at (b)(6) 2020 visit, patient voiced complaint of blurry vision only after work which would persist for minutes to hours." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5- the reporter indicated that the surgeon implanted a 12.1 mm ticml12.1 implantable collamer of diopter -14.00/3.0/086 (sphere/cylinder/axis) lens into the patient's right eye (od) on (b)(6) 2020.Accommodative spasms, refractive change overtime, and foggy vision were observed.Lens remains implanted.Cause of the event is reported as unknown.Reportedly on (b)(6) 2020, "the patient voiced a complaint of blurry vision only after work which would persist for minutes to hours." the problem was not resolved.Additional information has been requested but none has been forthcoming.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: 11169226
• Report Number: 2023826-2021-00069
• Device Sequence Number: 14343338
• Product Code: QCB
• UDI-Device Identifier: 00841542105279
• UDI-Public: 00841542105279
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: TMICL12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR