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

Model Number VICMO13.2

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Code Available (3191)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -07.50 diopter, in the patient's eye on (b)(6) 2020.The surgeon noted foreign bodies, similar to icl material on the front surface of the lens, after the lens was injected into the eye.There was no damage to the lens and patient's vision, intraocular pressure and vault were normal.There was some iris depigmentation that had occurred.The lens remained implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

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.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
• MDR Report Key: 10049232
• MDR Text Key: 190771189
• Report Number: 2023826-2020-01065
• Device Sequence Number: 1
• Product Code: MTA
• 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: 04/23/2020

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: 07/31/2022
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other