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 Endophthalmitis (1835); Hyphema (1911); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/07/2022

Event Type  Injury  

Manufacturer Narrative

Pt info: unk.Health impact - additional surgery: (b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -10.00 diopter, in the patients right eye (od), on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to endophthalmitis.Diagnostics were performed.Anterior chamber irrigation/evacuation of visco/fluids and a vitrectomy were performed.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5: post-op, the patient reported that there was a black object in his right eye.The eye felt foggy and hyphema was found.The lens was removed and hormone therapy was given.The condition did not improve the next day and a vitrectomy was performed.The patient is under observation and treatment.Additional information has been requested but none has been forthcoming.H6: health impact- clinical code: 4581 - foggy.H6: health effect impact code: 4644 - hormone therapy.H6: device history record (dhr) review: 3331 - 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.Claim#: (b)(4).

Manufacturer Narrative

B5: post-op, the patient was implanted with silicone oil in the glassectomy surgery, the best corrected visual acuity was corrected to 20/33 in the review.The latest review feedback showed that the patient's own posterior capsular crystals were opacities, and cataract surgery would be performed in the future.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15465141
• MDR Text Key: 300387748
• Report Number: 2023826-2022-03169
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

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 Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 11/09/2022
• Supplement Dates FDA Received: 10/28/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2022
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male