MAUDE Adverse Event Report: BAUSCH + LOMB HYDROVIEW INTRAOCULAR LENS

Model Number H60M

Device Problems Calcified (1077); Material Opacification (1426)

Patient Problems Calcium Deposits/Calcification (1758); No Information (3190); No Code Available (3191)

Event Date 11/24/2004

Event Type  Injury  

Manufacturer Narrative

This event was discussed in the literature article, "multiple elements in the deposits of opacified hydroview intraocular lens" by jui-yang lai, ms, ko-hua chen, md, wen-ming hsu, md, te-hsiao lee, md, and shan-yan lin, phd.Published 24-nov-2004.¿ please find the article attached.According to the literature, using edx spectroscopy, the elements of deposits on the iol optics were calcium and phosphorus.Sem photographs demonstrated multiple microspheres of similar sizes (<2 m diameter) that consisted of calcium and phosphorus.The oxygen content of iol optic was almost equal 35.73 to 33.03.The main components of deposits (calcium and phosphate) were not evenly distributed but decreased centrifugally.It may suggest that when the iol opacification occurred, the deposits formed on the outer periphery of the optic and then spread progressively toward the center of the optic.The lens serial and lot numbers were not provided in the study.Investigation of this event is in progress.A supplement report will be submitted upon completion of the investigation.

Event Description

It was reported in a literature case that an explanted intraocular lens (iol) lens exhibited fine, white, granular, and homogenous deposits.Additional information has been requested from the study contact.

Manufacturer Narrative

The lot number was not identified, and the lens was not returned for evaluation.The testing performed in the context of the study could not be replicated/confirmed internally.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Calcification is reported in the risk analysis and the directions for use as a known procedure complication for this lens.The most probable root cause is a known procedure complication.As this product has been discontinued, no corrective action is necessary at this time.

• Brand Name: HYDROVIEW INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 9777707
• MDR Text Key: 183918126
• Report Number: 0001313525-2020-00049
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/31/2020

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: Health Professional
• Device Model Number: H60M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention