MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: information unknown, not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis intraocular lens (iol) was explanted from the patient's left (os) eye because the surgeon noticed there is no capsular support during post operative exam.Vitrectomy along with sutures were used to complete the procedure.There is no confirmation that the patient has lost more than 2 lines of visual acuity, but vision line is noted 20/40.The replacement lens is a non-johnson and johnson lens.No additional information provided.
Additional Manufacturer Narrative
Additional information received, that the patient's capsule rent had extended posteriorly with vitreous prolapse.Section h6, clinical code has been updated from 4582 to 2142 for vitreous loss.And 2639 added to capture capsule rent.Section d9: device available for evaluation? yes.Section d9: returned to manufacturer: 1/25/2021.Section h3: device returned to manufacturer? yes.Device evaluation: the product was returned to the manufacturing site.The lens was cleaned and visual inspection under magnification revealed, that the lens was received cut (but not separated).Which is consistent with a lens, that 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 records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed, no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product 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 IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco, puerto rico 00610
• MDR Report Key: 11142779
• Report Number: 2648035-2021-07039
• Device Sequence Number: 13625424
• Product Code: HQL
• UDI-Device Identifier: 05050474534629
• UDI-Public: (01)05050474534629(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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: 76 YR