MAUDE Adverse Event Report: BAUSCH + LOMB INCORPORATED RENU FRESH MULTI-PURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number MB2420

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Erosion (1750); Corneal Abrasion (1789); Corneal Edema (1791); Corneal Perforation (1792); Corneal Ulcer (1796); Hypopyon (1913); Keratitis (1944); Neovascularization (1978); Scar Tissue (2060); Uveitis (2122); Corneal Infiltrates (2231); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

The complaint sample was not returned for evaluation.A review of the lot batch records is in progress.Additional medical information has been requested.Based on available information, no casual factors can be determined and no conclusion can be drawn.

Event Description

Consumer reported they were diagnosed with an eye infection (fungal fusarium) after using the solution for an extended period of time.A regulatory agency (b)(4) yellow card (reference: report overview (b)(4)) was received regarding the event.Here, the practitioner indicated that the patient had a case of fusarium keratitis in (b)(6) 2016 that resulted in a corneal perforation which required corneal gluing.Attempts to obtain additional information regarding the event are ongoing.

Manufacturer Narrative

Attempts to obtain additional event details have been unsuccessful.The device was not returned for evaluation.A review of the lot batch record and chemical and microbial testing of a retain sample concluded this product was formulated, manufactured and packaged according to local and global specifications.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Manufacturer Narrative

Additional information: the doctor indicated that in her opinion the fungal keratitis was associated with contact lens wear, but she could not predict the role of the solution.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

An event report was received from the eye care practitioner.The doctor indicated that the patient had a fusarium fungal keratitis of the left eye that included a full-thickness perforation.The patient has a 9-10 mm central corneal scar that has resulted in permanent loss of vision.Treatment included gluing of the corneal perforation, along with nystatin, veroconazole drops and tabs as rx products.The doctor indicated that in her opinion the fungal keratitis was associated with contact lens wear, but she could not predict the role of the solution.Medical information provided indicated the event occurred in (b)(6) 2017 but an exact date was not provided.

Manufacturer Narrative

The complaint sample was returned for evaluation, however, the sample was insufficient to perform all required testing.The results of the chemical and microbiological testing performed were all within specification.A review of the lot batch record and complete chemical and microbial testing of the retains concluded this product was formulated, manufactured and packaged according to local and global specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: RENU FRESH MULTI-PURPOSE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): BAUSCH + LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB-IOM S.P.A; via pasubio 34; 20050 macherio; milan 20846 ; IT 20846
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 6412940
• MDR Text Key: 70247404
• Report Number: 0001313525-2017-01847
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K020802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2017

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: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Lot Number: MB2420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/05/2017
• Supplement Dates FDA Received: 04/14/2017; 04/28/2017; 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR