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

Model Number	MICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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).
Additional 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)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6359091
• Report Number: 2023826-2017-00250
• Device Sequence Number: 984960
• Product Code: MTA
• UDI-Device Identifier: 00841542103275
• UDI-Public: (01)00841542103275(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 03/21/2017; 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR