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

Model Number MICL13.2

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

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned dry and there was evidence of white and clear residue.Method: lens work order search.Result: a lens work order search was performed and no similar complaints were found.Conclusion: based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -9.0 diopter, in the patient's left eye (os) on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to toxic anterior segment syndrome (tass), which was treated like endophthalmitis.A vitrectomy was performed.The reporter indicated the cause of the event was unknown, but was not product related.The reporter indicated cultures were taken and were consistently negative.The retina specialist recommended a vitrectomy, which was performed on (b)(6) 2017.The patients post-op bcva was 20/25.

Manufacturer Narrative

Device history record review: based on the results of the investigation, all released devices from the associated work order(s), including the suspect 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).

Manufacturer Narrative

Concomitant medical products: cartridge model sfc-45 fp - lot number unk.Corrected data: date returned to mfr previous date is incorrect, correct date is 02/08/2017.(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6359091
• MDR Text Key: 68349194
• Report Number: 2023826-2017-00250
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103275
• UDI-Public: (01)00841542103275(17)171130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2017

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: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2017; 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR