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

Model Number VICMO13.2

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

Patient Problems Cataract (1766); Endophthalmitis (1835); Vitrectomy (2643); No Code Available (3191)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, diopter -16.0 into the patient's right eye (od) on (b)(6) 2019.One day post-op the patient had exaggerated inflammation and exudates in the eye.The patient was diagnosed with acute endophthalmitis and immediately was injected with intraocular antibiotics.Vitreous biopsy sample revealed pseudomonas infection.Autoclave indicators passed.Ot and air cultures reported negative.Instruments and consumables reported negative for any microbiological growth.Vitreo-retinal surgery, cataract extraction, and icl explant performed.Bcva=6/18.Infection is currently inactive.

Manufacturer Narrative

Reporter indicated that vitrectomy surgery was performed and the patient's status is stable, with vision at 6/24p.Claim#: (b)(4).

Manufacturer Narrative

Method code 3331, 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 contributed to the complaint issue.(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
• MDR Report Key: 8519015
• MDR Text Key: 142100741
• Report Number: 2023826-2019-00607
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: VICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 05/16/2019; 08/22/2019
• Supplement Dates FDA Received: 06/12/2019; 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR