MAUDE Adverse Event Report: BAUSCH + LOMB HYDROVIEW INTRAOCULAR LENS

Model Number UNKNOWN HYDROVIEW

Device Problem Material Opacification (1426)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Insufficient Information (4580)

Event Date 11/29/2021

Event Type  Injury  

Event Description

It was reported that an intraocular lens (iol) was explanted from the left eye approximately twenty years post implant due to presumed opacification.Additional information has been requested.

Manufacturer Narrative

Although requested, a lot number was not provided; therefore, a device history record review was not performed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Because the lens was not returned it is not possible to determine whether the opacification observed by the physician is due to calcification or some other mechanism; however, three (3) major types of calcification have been identified: the primary form refers to calcification is caused by factors inherent to the iol design or material.The secondary form refers to deposition of calcium onto the surface of the iol caused by environmental factors (e.G.Changes in the aqueous surrounding the implanted iol associated with pre-existing or concurrent diseases, or due to additional surgical intervention).By definition, it is not related to any problem with the iol itself.The third form is a (b)(6) or pseudo-calcification in which other pathology is mistaken for calcification or (b)(6) staining for calcium occurs.Based on the available information, the root cause of this event could not be conclusively determined.

Event Description

Additional information was received indicating, approximately sixteen years post-implant, blurred vision, poor vision, and reduced visibility of the fundus were found in the patients left eye.Lens opacification was observed possibly by calcification.The patient was not hospitalized.The final outcome was patient recovered.

Manufacturer Narrative

Additional information.

Manufacturer Narrative

Corrected information to h6, h10/11: based on the available information, the root cause is associated with lens calcification, which is a known procedure complication for hydroview iols.

Event Description

This report is for the left (os) eye.Please reference mdr 0001313525-2021-00023 re od iol.

Manufacturer Narrative

One iol was returned for evaluation.The returned lens appears to be a hydroview lens; however, the part number, lot number and serial number could not be verified.Visual inspection found the lens was in two pieces.The optic had a cloudy white appearance in the center and some areas with an orange peel appearance.A chemical stain test was performed, and the presence of calcium was confirmed.

• Brand Name: HYDROVIEW INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• 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: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 13056333
• MDR Text Key: 282907502
• Report Number: 0001313525-2021-00163
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN HYDROVIEW
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 91 YR
• Patient Sex: Female