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

Model Number	TMICL12.1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 a 12.1 mm, tmicl12.1, -9.0/3.5/070 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a longer length lens due to lens rotation not associated to a low vault.It was reported that this exchange resolved the problem.In the reporter opinion the cause of the even was due to lens being too small.Reportedly, repositioning was not performed.However, it was reported that the repositioning resolved the problem.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Patient code: 2137 - refractive change over time.Claim# : (b)(4).
Additional Manufacturer Narrative
Corrected data: if follow-up, what type: "additional information" is not applicable and should be corrected to "correction" in previous mdr.Event: "on 04 apr 2019 the lens was exchanged for a longer length lens due to lens rotation not associated with low vault and refractive change over time." claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated that the lens was not repositioned.Device evaluation: lens was returned in liquid, in a lens vial.The vial was returned taped to paper.Visual inspection found no visible damage to the lens.(b)(4).
Additional Manufacturer Narrative
(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 91016
• MDR Report Key: 8552784
• Report Number: 2023826-2019-00666
• Device Sequence Number: 13889315
• Product Code: QCB
• UDI-Device Identifier: 00841542104654
• UDI-Public: 00841542104654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/27/2019

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: 01/31/2021
• Device Model Number: TMICL12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 06/26/2019; 07/16/2019; 07/29/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/22/2019; 07/01/2019; 07/29/2019; 08/07/2019
• 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-PF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR