MAUDE Adverse Event Report: BAUSCH + LOMB TRULIGN TORIC POSTERIOR CHAMBER IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number BL1UT

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Visual Impairment (2138); Zonular Dehiscence (2698)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that a patient's intraocular lens dislocated due to zonular dehiscence in the right eye post-surgery.The patient experienced decreased vision as a result.Two months post-op, the surgeon performed a lens reposition.Four months post-op, the surgeon placed a capsular tension ring in the eye and also decided to use the piggyback technique.The dehiscence was causing the lens to sit further posteriorly, so a +2.00d secondary lens was also placed in the eye.The cause of the zonular dehiscence is unknown.Regarding prognosis, the surgeon stated that the lens is in good position.

Manufacturer Narrative

The lens remains implanted, so it is not available for return.A device history record (dhr) review did not find any nonconformities or anomalies related to this event.Based on the available information, a root cause for the reported event could not be determined.

• Brand Name: TRULIGN TORIC POSTERIOR CHAMBER IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7380043
• MDR Text Key: 103775317
• Report Number: 0001313525-2018-00074
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

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: 06/30/2020
• Device Model Number: BL1UT
• Device Catalogue Number: BL1UT2150200
• Device Lot Number: 7556011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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): Other