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

Model Number	TMICL13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/09/2019
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 tmicl13.2 implantable collamer lens, -9.00/+2.5/094 (sphere/cylinder/axis), in the patients left eye (os) in 2019.The reporter has indicated the surgeon plans to explant and exchange the lens for a shorter lens due to the lens has vaulted forward and possibly rubbing against the iris.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional data: b5:the lens was implanted on (b)(6) 2019.The lens was explanted on (b)(6) 2020 due to excessive vaulting, significant reduction of irido-corneal angles, pigment dispersion and intermittent pain in the dark.The lens was exchanged for a shorter lens and the problem was resolved.The cause of the event was unknown.H3 - device evaluation: the lens was returned in liquid in a lens vial.Visual inspection found no visible damage to the lens.H6 - patient code: 3191 - secondary surgical intervention, lens exchange.H6 - patient code: 3191 - significant reduction of irido-corneal angles; pigment dispersion.H6 - device code: 1494 - this lens model is contraindicated for patients with age less than that of 21 years.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10135938
• Report Number: 2023826-2020-01166
• Device Sequence Number: 14249216
• Product Code: QCB
• UDI-Device Identifier: 00841542108904
• UDI-Public: 00841542108904
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: 02/28/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: Other; Required Intervention
• Patient Age: 20 YR