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

Model Number VTICMO13.2

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a 13.2mm, vticmo13.2, -18.00/2.0/129 (sphere/cylinder/axis) implantble collamer lens was implanted upside down in the patients right eye (od) on (b)(6) 2018.It was reported that the surgeon removed the lens and implanted it again.Once the lens was inside the eye, the surgeon realized that the lens was damaged and removed the lens again.Corneal edema and corenal decompensation were observed.The reporter stated that the cause of the adverse events was the surgeon/surgical procedure.The device did not cause or contribute to the event.Patient is awaiting icl repalcement and the eye is okay.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Lens was returned dry, in a micro-centrfuge vial.There was clear surgical residue on product.Visual inpsection found the haptic torn and deformed; and presence of residue on lens surface.(b)(4).

Manufacturer Narrative

Additional data: new information: "surgeon implanted the new lens (same parameters as the first one since the problem was that he broke the lens) vticmo 13.2 -18/+2.0/108.Patient's av is satisfying, vault is normal".Claim# (b)(4).

Manufacturer Narrative

Corrected data: (b)(4).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7791689
• MDR Text Key: 117419169
• Report Number: 2023826-2018-01181
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/17/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 10/18/2018; 11/02/2018; 01/07/2019
• Supplement Dates FDA Received: 10/19/2018; 10/23/2018; 11/02/2018; 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR