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

Model Number	MICL 12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned in biohazard bag.Visual inspection found no visible damage to the lens.(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that 12.6mm, micl 12.6, -4.00 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was explanted due to low vault and refractive surprise.The reporter stated, "blurry and double vision post op, no patient injury.Problem resolved after explanting the lens".Patient is stable, vision was better and cloudiness was gone.No plans to implant another lens, patient did not want the lens replaced.
Additional Manufacturer Narrative
Device code 1494: off-label use; acd < 3.00mm.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
• MDR Report Key: 8850039
• Report Number: 2023826-2019-01369
• Device Sequence Number: 19185606
• Product Code: MTA
• UDI-Device Identifier: 00841542102902
• UDI-Public: 00841542102902
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 08/31/2020
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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: CARTRIDGE MODEL# SFC-45, LOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK; CARTRIDGE MODEL# SFC-45, LOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR