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

Model Number	MICL13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -14.5 diopter, into the patient's right (od) eye.The surgeon reports an unexpected refractive result with anterior vault.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned dry in a specimen cup with residue on the lens.Visual inspection found the haptic torn and foreign residue on the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: the reporter indicated that the surgeon implanted a 13.2mm micl 13.2 implantable collamer lens, 14.5 diopter, into the patient's right (od) eye.The surgeon reports an unexpected refractive result with anterior vault.Lens was explanted.Attempts to obtain additional information have not been successful.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
• MDR Report Key: 10491987
• Report Number: 2023826-2020-01957
• Device Sequence Number: 19502282
• Product Code: MTA
• UDI-Device Identifier: 00841542103381
• UDI-Public: 00841542103381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 09/22/2021
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/19/2020; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention