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

Model Number	TMICL13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Device evaluation : lens was returned in liquid, in lens vial.Visual inspection found one of the haptics torn.(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, tmicl13.7, -12.00/2.0/089 implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault and significant reduction of irido-corneal angles.It was reported that the exchanged lens resolved the problem but "still a little high vault".Abnormal sulcus to sulcus width was reported as cause of event.
Additional Manufacturer Narrative
Corrected data: b5- " glare and halos were observed." should be added in the initial mdr.Claim# (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: 9492867
• Report Number: 2023826-2019-02419
• Device Sequence Number: 297223
• Product Code: QCB
• UDI-Device Identifier: 00841542111485
• UDI-Public: 00841542111485
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 05/31/2021
• Device Model Number: TMICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: 33 YR