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	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon decided a 3 piece lens and hence, the intraocular lens was removed from patient's eye and replaced with another lens of different model during the same procedure.No issue was reported against the lens.However, a 10-0 nylon suture was used.No further information was available.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section a2: date of birth: (b)(6) 1949.Section a3: gender: male.Section a5: ethnicity: hispanic.Section b5: additional information revealed that the original lens was changed to a 3 piece lens as it dislocated through a peripheral tear during viscoat removal from the patient's right eye.The incision was enlarged and an anterior vitrectomy was performed.The suture was placed secondary to need for corneal wound expansion for sulcus iol placement.Section h6: health effect - impact code: 4625- additional surgery (anterior vitrectomy).Section h6: health effect - impact code: 4625- additional surgery (incision enlargement).Section h6: health effect - clinical code: 2639- capsular bag tear.Section h6: health effect - clinical code: 4581- device dislocated.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 PR 00610
• MDR Report Key: 12110305
• Report Number: 2648035-2021-08069
• Device Sequence Number: 19960393
• Product Code: HQL
• UDI-Device Identifier: 05050474531611
• UDI-Public: (01)05050474531611(17)240927
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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: 09/27/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 08/20/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/02/2021; 09/09/2021
• 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