MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problem Break (1069)

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Age/ date of birth: unknown/ not provided.Sex/ gender: unknown/ not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the trailing haptic of an intraocular lens (iol) detached from the root when it was implanted.It was noted that the haptic broke when it was set in the cartridge.The iol was cut with a lens cutter in the eye and then the procedure was completed with a back-up lens of the same model.The removed lens was discarded by the clinic.It was reported that the day after the lens was implanted, the cornea seemed to become cloudy.The cloudiness was seen throughout the cornea which remained even one week after the operation; however, it has subsided over time.It was indicated that the physician thinks that the prolonged operation time in the eye for the removal of the lens could have impacted the eye with a small pupil.No further information was provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed, as the product was not returned (the lens was discarded at the customer site).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found, during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed, that no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision has been submitted.

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11038304
• MDR Text Key: 222366080
• Report Number: 2648035-2020-00948
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)250316
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other