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

Model Number	TMICL13.2
Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unk.Date of event: unk.Implant date: unk.Explant date: unk.(b)(4) - this lens model is contraindicated for patients with age more than that of 45 years.Claim # (b)(4).
Event or Problem Description
A 13.2mm tmicl13.2 implantable collamer lens, -10.50/+1.0/132 (sphere/cylinder/axis), is being returned to the manufacturer and the reason is unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional data: d6a: (b)(6) 2021.Corrected data: b5: a 13.2mm tmicl13.2 implantable collamer lens, -10.50/+1.0/132 (sphere/cylinder/axis) was implanted in the patients right eye (od) and remained implanted.There was no problem with the lens and the lens will not be returned.This complaint was reported in error.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: 12437008
• Report Number: 2023826-2021-03473
• Device Sequence Number: 14792648
• Product Code: QCB
• UDI-Device Identifier: 00841542109086
• UDI-Public: 00841542109086
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1