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

Model Number Z9002

Device Problems Difficult to Insert (1316); Defective Component (2292)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.If implanted, give date: not applicable, there is no indication the lens was implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) had a haptic so big the surgeon could not get it positioned.The capsule tore and a vitrectomy was required, however, it was not product related.It was also reported the patient will be returning aphakic.No additional information was provided.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

Manufacturer Narrative

Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 08/14/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the z9002 lens was returned in its original package.Visual inspection using magnification was performed to the returned sample: loose fibers/particles were observed on lens relating to handling the unit out of a sterile environment.Residues of lubricant material were also observed on lens.No damaged was observed to the lens.Both haptics were observed damaged/distorted.The sample returned condition is consistent with a lens that was handled and prepared for surgical process.The complaint issue reported could not be verified.Based on the analyzed of the returned sample, there is no indication of a product quality deficiency.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• 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: 10318331
• MDR Text Key: 200217544
• Report Number: 2648035-2020-00548
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530768
• UDI-Public: (01)05050474530768(17)220307
• Combination Product (y/n): Y
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention