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

Model Number	MICL12.1
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient sex, weight, ethnicity and race: unk.Date of event, implant date: unk.(b)(4).This lens model is contraindicated for patients with age less than that of 21 years.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1mm micl12.1 implantable collamer lens, -10.00 diopter, in the patients right eye (od) on (b)(6) 2018.The lens will be removed and exchanged.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional data: h6: health impact- clinical code: 4581 - refractive change overtime, keratoconus.Corrected data: b5: the reporter indicated the surgeon implanted a 12.1mm micl12.1 implantable collamer lens, -10.00 diopter, in the patients right eye (od) on (b)(6) 2018.The lens was removed on (b)(6) 2022 due to patient experienced refractive change overtime and blurred vision.The vision was worsening and cornea topography showed keratoconus developing ou versus 6 months prior.The lens was replaced with a different model (vicm5) but same length lens and the problem was resolved.Post-op, the va is good and patient is doing well, has some night time glare caused by lights.Cause of the event was unknown.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15591731
• Report Number: 2023826-2022-03483
• Device Sequence Number: 14007143
• Product Code: MTA
• UDI-Device Identifier: 00841542102759
• UDI-Public: 00841542102759
• Combination Product (Y/N): N
• 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: 2018
• Device Explanted Year: 2022
• 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): 09/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: MICL12.1
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2017
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male