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

Model Number	Z9002
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is around (b)(6) 2020 as the timeframe provided for symptom onset is six months ago.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient¿s left eye due to lens dislocation.It was replaced with a non-johnson and johnson iol but same diopter power.A vitrectomy was performed.No other information was provided.
Additional Manufacturer Narrative
Section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/6/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: returned lens was received, submerged in an unknown solution inside a specimen cup.Additional documentation was received as well.The lens was cleaned and visual inspection under magnification revealed, that the lens was returned cut in half with a bent haptic.Which may have occurred, when the lens was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed, that there was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed, that two additional complaints were received from this production order, but no product malfunction or discrepancy could be identified.And no escalation is required.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 & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11099305
• Report Number: 2648035-2020-00978
• Device Sequence Number: 3630662
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)181227
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2013
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR