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

Model Number	MICL 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry, in contact lens case, clear surgical residue on product.Visual inspection found haptic torn and residue on 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 the surgeon implanted a 12.6mm micl12.6, -6.5 diopter, implantable collamer lens, into the patient's eye on (b)(6) 2019.Reportedly, "patient wanted better near vision in eye and some astigmatism was found to be related to it as well." on (b)(6) 2019 the lens was removed and exchanged with a toric icl.This resolved the problem.Per reporter on (b)(6) 2019, "patient is happy with vision and says continually improving.".
Additional Manufacturer Narrative
Result code: 213 reported in initial mdr is corrected to 114.Claim#: (b)(4).
Additional Manufacturer Narrative
The lens explant date of (b)(6) 2019 is not applicable.The explant date was on (b)(6) 2019.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: 8887955
• Report Number: 2023826-2019-01354
• Device Sequence Number: 16190218
• Product Code: MTA
• UDI-Device Identifier: 00841542102957
• UDI-Public: 00841542102957
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 08/02/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 10/22/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/03/2019; 10/23/2019
• 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