MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT AO INTRAOCULAR LENS

Model Number LI61AO

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Lens haptic bent while insertion, surgeon removed the lens, enlarged the incision and used sutures.Additional information has been requested but has not been received.

Manufacturer Narrative

Based on the additional information received, this event is no longer considered reportable.

Event Description

The haptic reportedly bent or kinked during preparation for use.There was no patient contact.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: faranak spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6664973
• MDR Text Key: 78347224
• Report Number: 0001313525-2017-02656
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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: 05/31/2021
• Device Model Number: LI61AO
• Device Lot Number: 4655314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 05/26/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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