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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Halo (2227); No Code Available (3191)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -12.0 diopter, in the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to excessive vaulting and significant reduction of irido-corneal angles.The surgeon had performed a limbal relaxing incision but it was leaking so the surgeon sutured the incision closed.The lens was exchanged for a shorter lens and the problem was resolved.Post-op, there was improved vision and vault but with mydriasis at day one and patient complained of halos.Intraocular pressure was elevated but was treated aggressively with diamox and topical drops.The cause of the event was unknown.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned dry in a zip loc bag.Visual inspection found no visible damage and foreign residue on the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: d9- "(b)(6) 2020" should be corrected to "(b)(6) 2020" in the previous mdr.H6- patient code 1937 should be removed from initial mdr.H6- patient code 3191- (mydriasis) should be removed from initial mdr.H6- device code 3001 should be removed from initial mdr.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: 9988375
• Report Number: 2023826-2020-00945
• Device Sequence Number: 11736585
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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: 06/30/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020; 11/05/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/29/2020; 12/05/2020
• 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
• Patient Age: 25 YR