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

Model Number	MICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.00 diopter, in the patients right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to low vaulting.The lens was exchanged with a longer lens and the problem was resolved.The patients post-op best corrected visual acuity (bcva) was 20/40 (pre-op bcva was 20/20) so claim # (b)(4) (mfr report # 2023826-2020-00408) was opened.To date, the bcva has not increased but vault is better.The cause of the event was unknown.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned in liquid in lens vial.Visual inspection found no visible damage to the lens.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - it should have been specified that the lens was explanted and replaced in a seperate surgery on the same date.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: 9782973
• Report Number: 2023826-2020-00407
• Device Sequence Number: 10941298
• Product Code: MTA
• UDI-Device Identifier: 00841542103008
• UDI-Public: 00841542103008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 02/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 04/30/2021
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 07/15/2020; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR