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

Model Number VTICMO13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 09/29/2020

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.Claim # (b)(4).

Event Description

The reporter indicated that a 13.2mm, vticmo13.2, -14.50/+2.00/91 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2020.On (b)(6) 2020 the lens was explanted due to endophthalmitis, additional intervention was performed (anterior chamber irrigation/evacuation of visco/fluids and intraocular injection-cefrazidime).It was reported that a culture was not performed, doctor suspects cause is device related, patients current condition is stable and bcva was 20/20.Endophthalmitis was resolved through treatment and will continue to be monitored.

Manufacturer Narrative

Additional information: h3-device evaluation- lens returned in a microcentrifuge vial with moisture.Visual inspection found optic torn and haptic torn.H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(6).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10868449
• MDR Text Key: 217143954
• Report Number: 2023826-2020-02719
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 10/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR