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

Model Number	TMICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	02/13/2020
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 13.2mm, tmicl13.2, -14.50/2.0/089 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2020.Excessive vault and corneal edema were observed.The lens was intraoperatively removed with enlargement of pi and yag.Cause of the event is reported as patient related factor.On patient's (b)(6) 2020 "mild persistent corneal edema observed and patient considering placing small icl." per the surgeon on (b)(6) 2020, "patient prefers to use glasses and contact, not to attempt another icl surgery.".
Additional Manufacturer Narrative
Additional information: b1-adverse event.B2-required intervention to prevent permanent impairment/damage (devices).B5-additional information- original pi performed 1 week prior to surgery; after the icl was placed the vault was very high and the anterior chambers were very shallow.At 1-2 hrs post-op surgeon enlarged the pi to insure they were patent but this did not lead to deepening of the anterior chamber over the next hour.Surgeon then decided to explant the lens.This was done same day different surgery.H3-device evaluation-lens returned dry in pouch with clear surgical residue on product.Visual inspection found haptic torn and residue on the lens.Corrected data: h1-malfunction in initial mdr is corrected to serious injury.(b)(4).
Additional Manufacturer Narrative
Corrected data: b4- in initial mdr is corrected to (b)(6) 2020.B5- patient also experienced "extremely narrow angles" should be included in initial mdr.D10- lens returned date in previous mdr is corrected to (b)(6) 2020.G4- in initial mdr is corrected to (b)(6) 2020.H6- patient code 3191-narrow angles.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
• MDR Report Key: 9824673
• Report Number: 2023826-2020-00425
• Device Sequence Number: 1551617
• Product Code: QCB
• UDI-Device Identifier: 00841542109666
• UDI-Public: 00841542109666
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 06/03/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/22/2020; 06/03/2020
• 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: 32 YR