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 Problems Endophthalmitis (1835); Loss of Vision (2139); Vitrectomy (2643); No Code Available (3191)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order (s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contribute to the complaint issue.

Event Description

The reporter indicated that a 13.2mm, vticmo13.2 implantable collamer lens, -16.50/1.50/165 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2020.Endophthalmitis and loss of vision were observed.Diagnostics (prp of vitreous sample) and medical intervention (vitreous biopsy, core vitrectomy, intravitreal vancomycin, intavitreal piperacillin tazobactam) were performed.Vitreous biopsy sample revealed pseudomonas aeruginosa.On (b)(6) 2020 the lens was explanted and additional intervention/treatment was performed (anterior chamber wash, vitreous biopsy, vitrectomy, fluid- air exchange, silicone oil injection, intravitreal vancomycin, intravitreal piperacillin tazobactam, intravitreal dexamethsone).Vitreous biopsy was sent for repeat grams stain, koh mount, culture and sensitivity for bacteria and fungus.On (b)(6) 2020 vitreous culture showed no growth.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Information received on 21 sep 2020: patient had no general health conditions.Patient was prepped with povidone iodine.A prophylactic intracameral (moxifloxacin) antibiotic was used at the time of implantaion.Patient has pl+ve vision in the affected eye.Visual prognosis is not good.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10463780
• MDR Text Key: 204753358
• Report Number: 2023826-2020-01914
• 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: 07/29/2020

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: 07/31/2022
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR