MAUDE Adverse Event Report: STAAR SURGICAL COMPANY INTRAOCULAR LENS

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

Patient Problems Cataract (1766); Retinal Detachment (2047); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

An article was received that cited a retrospective clinical study that found 10 patients implanted with the phakic intraocular lens (piol) had developed retinal detachment.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

A journal reports 10 cases of retinal detachment, one cataract, one case requiring multiple surgeries.And two explants associated with unknown model piols.Anatomical success with visual improvement was achieved in all 10 eyes.It is not known if all the lenses in the study were manufactured by staar or if it included lenses manufactured by other companies.(b)(4).Claim#: (b)(4).

Manufacturer Narrative

The reporter indicated they have concluded that the incidence of retinal detachment in eyes with phakic iol is no more than the natural history of the disease (myopia).No more information was available.(b)(4).

• Brand Name: INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8593197
• MDR Text Key: 144517871
• Report Number: 2023826-2019-00758
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention